Maraviroc in Rheumatoid Arthritis

This study has been terminated.

(See Detailed Description.)

Sponsor:

Collaborator:

Pfizer

Information provided by:

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT00427934

First received: January 25, 2007

Last updated: November 10, 2010

Last verified: November 2010

History of Changes

Results First Received: October 6, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Arthritis, Rheumatoid
Interventions:	Drug: Maraviroc Drug: Maraviroc Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Maraviroc 150 mg BID (Pharmacokinetic [PK])	150 mg tablet was administered by mouth twice a day (BID) for 4 weeks with stable weekly doses of methotrexate (MTX).
Maraviroc 300 mg BID (PK)	300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (Proof-of-Concept [POC])	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Participant Flow: Overall Study

	Maraviroc 150 mg BID (Pharmacokinetic [PK])	Maraviroc 300 mg BID (PK)	Maraviroc 300 mg BID (Proof-of-Concept [POC])	Placebo (POC)
STARTED	8	8	78	34
Treated	8	8	77	33
COMPLETED	7	8	55	19
NOT COMPLETED	1	0	23	15
Adverse Event	1	0	5	4
Lack of Efficacy	0	0	5	2
Randomized But Did Not Receive Treatment	0	0	1	1
Unknown	0	0	11	5
Withdrawal by Subject	0	0	1	3

Baseline Characteristics

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Reporting Groups

	Description
Maraviroc 150 mg BID (PK)	150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (PK)	300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Total	Total of all reporting groups

Baseline Measures

	Maraviroc 150 mg BID (PK)	Maraviroc 300 mg BID (PK)	Maraviroc 300 mg BID (POC)	Placebo (POC)	Total
Number of Participants [units: participants]	8	8	77	33	126
Age, Customized [units: Participants]
< 18 years	0	0	0	0	0
18 to 44 years	1	0	15	6	22
45 to 64 years	4	8	48	21	81
> = 65 years	3	0	14	6	23
Gender [units: Participants]
Female	4	5	71	22	102
Male	4	3	6	11	24

Outcome Measures

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1. Primary:

American College of Rheumatology (ACR) 20% Responders at Week 12 [ Time Frame: Week 12 ]

Measure Type	Primary
Measure Title	American College of Rheumatology (ACR) 20% Responders at Week 12
Measure Description	A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient’s Assessment of Arthritis Pain (Visual Analogue Scale [VAS]), Patient’s Global Assessment of Arthritis (VAS), Physician’s Global Assessment of Arthritis (Categorical), Health Assessment Questionnaire – Disability Index (HAQ-DI), and C-Reactive Protein (CRP).
Time Frame	Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) was defined as an intent-to-treat analysis set that included all subjects randomized to treatment who had taken at least 1 dose of study medication. Missing values were imputed by the method of last observation carried forward (LOCF).

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	77	33
American College of Rheumatology (ACR) 20% Responders at Week 12 [units: Participants]	21	6

Statistical Analysis 1 for American College of Rheumatology (ACR) 20% Responders at Week 12

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	0.155
Percentage Difference ^[4]	9.09
90% Confidence Interval	( -6.16 to 21.83 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-value (one-sided) was based on Barnard exact test if more than 20% of expected cell counts were < 5 otherwise Pearson chi-square test.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

2. Secondary:

ACR 20% Responders at Weeks 1, 2, 4, and 8 [ Time Frame: Weeks 1, 2, 4, and 8 ]

Measure Type	Secondary
Measure Title	ACR 20% Responders at Weeks 1, 2, 4, and 8
Measure Description	A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 20% data were collected, but not analyzed.
Time Frame	Weeks 1, 2, 4, and 8
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. Missing values were imputed by the method of LOCF.

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	77	33
ACR 20% Responders at Weeks 1, 2, 4, and 8 [units: Participants]
Week 1	8	4
Week 2	12	5
Week 4	21	8
Week 8	23	7

Statistical Analysis 1 for ACR 20% Responders at Weeks 1, 2, 4, and 8

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	0.790
Percentage Difference ^[4]	-1.73
90% Confidence Interval	( -15.13 to 8.68 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 1
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

Statistical Analysis 2 for ACR 20% Responders at Weeks 1, 2, 4, and 8

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	0.477
Percentage Difference ^[4]	0.43
90% Confidence Interval	( -13.67 to 11.64 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 2
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

Statistical Analysis 3 for ACR 20% Responders at Weeks 1, 2, 4, and 8

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	0.370
Percentage Difference ^[4]	3.03
90% Confidence Interval	( -12.85 to 16.77 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

Statistical Analysis 4 for ACR 20% Responders at Weeks 1, 2, 4, and 8

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	0.175
Percentage Difference ^[4]	8.66
90% Confidence Interval	( -7.07 to 22.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

3. Secondary:

ACR 50% Responders at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]

Measure Type	Secondary
Measure Title	ACR 50% Responders at Weeks 1, 2, 4, 8, and 12
Measure Description	A subject was an ACR 50 responder if: the counts for both tender and swollen joints had reduced by 50% or more from baseline; and 3 out of the following 5 assessments showed reduction of 50% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 50% data were collected, but not analyzed.
Time Frame	Weeks 1, 2, 4, 8, and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. Missing values were imputed by the method of LOCF.

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	77	33
ACR 50% Responders at Weeks 1, 2, 4, 8, and 12 [units: Participants]
Week 1	1	0
Week 2	2	0
Week 4	2	2
Week 8	6	3
Week 12	8	3

Statistical Analysis 1 for ACR 50% Responders at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	0.420
Percentage Difference ^[4]	1.30
90% Confidence Interval	( -6.34 to 6.01 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 1
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

Statistical Analysis 2 for ACR 50% Responders at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	0.258
Percentage Difference ^[4]	2.60
90% Confidence Interval	( -5.08 to 7.95 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 2
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

Statistical Analysis 3 for ACR 50% Responders at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	1.000
Percentage Difference ^[4]	-3.46
90% Confidence Interval	( -14.39 to 3.42 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

Statistical Analysis 4 for ACR 50% Responders at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	0.899
Percentage Difference ^[4]	-1.30
90% Confidence Interval	( -13.56 to 7.92 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

Statistical Analysis 5 for ACR 50% Responders at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	0.489
Percentage Difference ^[4]	1.30
90% Confidence Interval	( -11.24 to 10.96 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

4. Secondary:

ACR 70% Responders at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]

Measure Type	Secondary
Measure Title	ACR 70% Responders at Weeks 1, 2, 4, 8, and 12
Measure Description	A subject was an ACR 70 responder if: the counts for both tender and swollen joints had reduced by 70% or more from baseline; and 3 out of the following 5 assessments showed reduction of 70% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 70% data were collected, but not analyzed.
Time Frame	Weeks 1, 2, 4, 8, and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. Missing values were imputed by the method of LOCF.

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	77	33
ACR 70% Responders at Weeks 1, 2, 4, 8, and 12 [units: Participants]
Week 1	0	0
Week 2	0	0
Week 4	0	1
Week 8	2	0
Week 12	0	1

Statistical Analysis 1 for ACR 70% Responders at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	1.000
Percentage Difference ^[4]	-3.03
90% Confidence Interval	( -13.59 to 1.28 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

Statistical Analysis 2 for ACR 70% Responders at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	0.258
Percentage Difference ^[4]	2.60
90% Confidence Interval	( -5.08 to 7.95 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

Statistical Analysis 3 for ACR 70% Responders at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	Barnard/Pearson chi-square test
P Value ^[3]	1.000
Percentage Difference ^[4]	-3.03
90% Confidence Interval	( -13.59 to 1.28 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.

5. Secondary:

Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12
Measure Description	Change from baseline at each visit was analyzed for tender/painful joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, metacarpophalangeal joints (MCP), proximal interphalangeal joints (PIP), and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 tender/painful joint count data were collected, but not analyzed.
Time Frame	Baseline, Weeks 1, 2, 4, 8, and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. Missing values were imputed by the method of LOCF.

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	77	33
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12 [units: joint count] Least Squares Mean ± Standard Error
Week 1	-0.81 ± 0.68	-1.91 ± 0.96
Week 2	-2.08 ± 0.76	-2.38 ± 1.08
Week 4	-4.00 ± 0.84	-4.01 ± 1.20
Week 8	-4.85 ± 0.85	-3.24 ± 1.21
Week 12	-4.89 ± 0.84	-3.41 ± 1.19

Statistical Analysis 1 for Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.335
Mean Difference (Final Values) ^[4]	1.10
90% Confidence Interval	( -0.79 to 2.99 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 1
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using analysis of covariance (ANCOVA) with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.816
Mean Difference (Final Values) ^[4]	0.30
90% Confidence Interval	( -1.82 to 2.41 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 2
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.996
Median Difference (Final Values) ^[4]	0.01
90% Confidence Interval	( -2.35 to 2.36 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.263
Mean Difference (Final Values) ^[4]	-1.61
90% Confidence Interval	( -3.98 to 0.76 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.294
Mean Difference (Final Values) ^[4]	-1.48
90% Confidence Interval	( -3.82 to 0.85 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

6. Secondary:

Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12
Measure Description	Change from baseline at each visit was analyzed for swollen joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, MCP joints, PIP joints, and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 swollen joint count data were collected, but not analyzed.
Time Frame	Baseline, Weeks 1, 2, 4, 8, and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. Missing values were imputed by the method of LOCF.

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	77	33
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12 [units: joint count] Least Squares Mean ± Standard Error
Week 1	-1.39 ± 0.49	-1.07 ± 0.70
Week 2	-2.25 ± 0.61	-2.51 ± 0.87
Week 4	-3.93 ± 0.54	-4.08 ± 0.77
Week 8	-4.48 ± 0.62	-3.03 ± 0.88
Week 12	-3.48 ± 0.66	-3.43 ± 0.95

Statistical Analysis 1 for Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.700
Mean Difference (Final Values) ^[4]	-0.32
90% Confidence Interval	( -1.70 to 1.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 1
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.799
Mean Difference (Final Values) ^[4]	0.26
90% Confidence Interval	( -1.45 to 1.97 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 2
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.867
Mean Difference (Final Values) ^[4]	0.15
90% Confidence Interval	( -1.35 to 1.66 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.167
Mean Difference (Final Values) ^[4]	-1.45
90% Confidence Interval	( -3.17 to 0.28 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.966
Mean Difference (Final Values) ^[4]	-0.05
90% Confidence Interval	( -1.91 to 1.81 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

7. Secondary:

Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Measure Description	The severity of arthritis was scored by the subject between 0 (no pain) and 100 (most severe pain) on a 100 mm VAS. Change from baseline at each visit was analyzed for Patient’s Assessment of Arthritis Pain. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Assessment of Arthritis Pain data were collected, but not analyzed.
Time Frame	Baseline, Weeks 1, 2, 4, 8, and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. Missing values were imputed by the method of LOCF.

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	77	33
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12 [units: scores on scale] Least Squares Mean ± Standard Error
Week 1	-3.96 ± 2.18	-3.62 ± 3.10
Week 2	-8.46 ± 2.65	-3.20 ± 3.77
Week 4	-8.35 ± 2.70	-9.08 ± 3.85
Week 8	-10.30 ± 2.98	-8.67 ± 4.24
Week 12	-8.30 ± 2.85	-6.09 ± 4.06

Statistical Analysis 1 for Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.925
Mean Difference (Final Values) ^[4]	-0.34
90% Confidence Interval	( -6.41 to 5.72 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 1
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline patient’s assessment of arthritis pain as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.239
Mean Difference (Final Values) ^[4]	-5.26
90% Confidence Interval	( -12.62 to 2.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 2
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline patient’s assessment of arthritis pain as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.872
Mean Difference (Final Values) ^[4]	0.73
90% Confidence Interval	( -6.79 to 8.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline patient’s assessment of arthritis pain as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.745
Mean Difference (Final Values) ^[4]	-1.63
90% Confidence Interval	( -9.91 to 6.65 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline patient’s assessment of arthritis pain as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.644
Mean Difference (Final Values) ^[4]	-2.22
90% Confidence Interval	( -10.14 to 5.71 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline patient’s assessment of arthritis pain as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

8. Secondary:

Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Measure Description	Subjects answered: “Considering all the ways your arthritis affects you, how are you feeling today?” Subjects responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly. Change from baseline at each visit was analyzed for Patient’s Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Global Assessment of Arthritis Pain data were collected, but not analyzed.
Time Frame	Baseline, Weeks 1, 2, 4, 8, and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. Missing values were imputed by the method of LOCF.

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	76	33
Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12 [units: scores on scale] Least Squares Mean ± Standard Error
Week 1	-4.70 ± 2.22	-2.34 ± 3.13
Week 2	-8.85 ± 2.48	-4.88 ± 3.49
Week 4	-10.00 ± 2.74	-9.02 ± 3.86
Week 8	-11.12 ± 2.93	-3.44 ± 4.13
Week 12	-8.55 ± 2.88	-6.78 ± 4.06

Statistical Analysis 1 for Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.524
Mean Difference (Final Values) ^[4]	-2.36
90% Confidence Interval	( -8.49 to 3.77 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 1
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline Patient’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.338
Mean Difference (Final Values) ^[4]	-3.96
90% Confidence Interval	( -10.80 to 2.87 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 2
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline Patient’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.830
Mean Difference (Final Values) ^[4]	-0.98
90% Confidence Interval	( -8.55 to 6.58 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline Patient’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.118
Mean Difference (Final Values) ^[4]	-7.68
90% Confidence Interval	( -15.76 to 0.40 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline Patient’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.712
Mean Difference (Final Values) ^[4]	-1.78
90% Confidence Interval	( -9.73 to 6.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline Patient’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

9. Secondary:

Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Measure Description	Physician's evaluation based on subject’s disease signs, functional capacity and physical exam. Response recorded using 5-point scale: 1=Very Good, 2=Good, 3=Fair, 4=Poor and 5=Very Poor. Change from baseline at each visit was analyzed for Physician’s Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy thus Week 16 Physician's Global Assessment of Arthritis Pain data were collected but not analyzed.
Time Frame	Baseline, Weeks 1, 2, 4, 8, and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. Missing values were imputed by the method of LOCF.

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	75	32
Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12 [units: scores on scale] Least Squares Mean ± Standard Error
Week 1	-0.30 ± 0.08	-0.22 ± 0.11
Week 2	-0.44 ± 0.09	-0.39 ± 0.12
Week 4	-0.49 ± 0.10	-0.44 ± 0.13
Week 8	-0.63 ± 0.10	-0.37 ± 0.14
Week 12	-0.49 ± 0.11	-0.36 ± 0.15

Statistical Analysis 1 for Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.540
Mean Difference (Final Values) ^[4]	-0.08
90% Confidence Interval	( -0.28 to 0.13 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 1
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline Physician’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.757
Mean Difference (Final Values) ^[4]	-0.04
90% Confidence Interval	( -0.28 to 0.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 2
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline Physician’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.767
Mean Difference (Final Values) ^[4]	-0.05
90% Confidence Interval	( -0.31 to 0.21 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline Physician’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.112
Mean Difference (Final Values) ^[4]	-0.26
90% Confidence Interval	( -0.52 to 0.01 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline Physician’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.490
Mean Difference (Final Values) ^[4]	-0.13
90% Confidence Interval	( -0.42 to 0.17 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline Physician’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

10. Secondary:

Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12
Measure Description	HAQ-DI assesses degree of difficulty experienced in daily activity categories (dressing/grooming, arising, eating, walking, hygiene, reach, grip and other activities) over the past week. There are 20 questions and difficulty is scored from 0 (none), 1 (some), 2 (much) and 3 (unable to do). Scores were then averaged to give the disability index (scale of 0 to 3). Change from baseline at each visit was analyzed. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 HAQ-DI data were collected but not analyzed.
Time Frame	Baseline, Weeks 1, 2, 4, 8, and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS.

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	77	31
Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12 [units: scores on scale] Least Squares Mean ± Standard Error
Week 1	-0.08 ± 0.05	-0.03 ± 0.07
Week 2	-0.22 ± 0.06	-0.04 ± 0.08
Week 4	-0.24 ± 0.06	-0.18 ± 0.09
Week 8	-0.25 ± 0.07	-0.03 ± 0.10
Week 12	-0.18 ± 0.08	-0.06 ± 0.13

Statistical Analysis 1 for Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.464
Mean Difference (Final Values) ^[4]	-0.06
90% Confidence Interval	( -0.19 to 0.07 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 1
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.068
Mean Difference (Final Values) ^[4]	-0.18
90% Confidence Interval	( -0.35 to -0.02 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 2
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.532
Mean Difference (Final Values) ^[4]	-0.06
90% Confidence Interval	( -0.23 to 0.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.063
Mean Difference (Final Values) ^[4]	-0.22
90% Confidence Interval	( -0.41 to -0.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.396
Mean Difference (Final Values) ^[4]	-0.12
90% Confidence Interval	( -0.36 to 0.12 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

11. Secondary:

Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12
Measure Description	Change from baseline at each visit were analyzed for CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 CRP data were collected, but not analyzed.
Time Frame	Baseline, Weeks 1, 2, 4, 8, and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. Missing values were imputed by the method of LOCF.

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	73	31
Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12 [units: mg/L] Least Squares Mean ± Standard Error
Week 1	1.20 ± 1.87	3.40 ± 2.67
Week 2	3.14 ± 2.06	1.81 ± 2.93
Week 4	3.36 ± 2.34	-1.30 ± 3.33
Week 8	2.33 ± 2.10	-1.14 ± 2.98
Week 12	2.35 ± 2.26	1.93 ± 3.22

Statistical Analysis 1 for Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.481
Mean Difference (Final Values) ^[4]	-2.20
90% Confidence Interval	( -7.36 to 2.96 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 1
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.698
Mean Difference (Final Values) ^[4]	1.33
90% Confidence Interval	( -4.34 to 6.99 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 2
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.233
Mean Difference (Final Values) ^[4]	4.65
90% Confidence Interval	( -1.79 to 11.10 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.320
Mean Difference (Final Values) ^[4]	3.48
90% Confidence Interval	( -2.29 to 9.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.912
Mean Difference (Final Values) ^[4]	0.41
90% Confidence Interval	( -5.81 to 6.64 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

12. Secondary:

Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12
Measure Description	DAS28-4 (CRP) was calculated using the following formula: DAS28- 4(CRP) = 0.56 √28 Tender Joint Count + 0.28 √28 Swollen Joint Count + 0.36natural logarithm(CRP + 1) + 0.014Patient Global Assessment + 0.96. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at each visit was analyzed for DAS28-4 (CRP). The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 DAS28-4 (CRP) data were collected, but not analyzed.
Time Frame	Baseline, Weeks 1, 2, 4, 8, and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS. Missing values were imputed by the method of LOCF.

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	72	31
Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12 [units: mg/L] Least Squares Mean ± Standard Error
Week 1	-0.23 ± 0.09	-0.17 ± 0.13
Week 2	-0.41 ± 0.12	-0.33 ± 0.17
Week 4	-0.64 ± 0.14	-0.65 ± 0.19
Week 8	-0.82 ± 0.15	-0.51 ± 0.21
Week 12	-0.73 ± 0.16	-0.63 ± 0.22

Statistical Analysis 1 for Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.653
Mean Difference (Final Values) ^[4]	-0.07
90% Confidence Interval	( -0.31 to 0.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 1
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.703
Mean Difference (Final Values) ^[4]	-0.08
90% Confidence Interval	( -0.41 to 0.26 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 2
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.968
Mean Difference (Final Values) ^[4]	0.01
90% Confidence Interval	( -0.37 to 0.39 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.210
Mean Difference (Final Values) ^[4]	-0.31
90% Confidence Interval	( -0.72 to 0.10 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 8
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.696
Mean Difference (Final Values) ^[4]	-0.10
90% Confidence Interval	( -0.53 to 0.33 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

13. Secondary:

Change From Baseline in Mean Orthostatic Blood Pressure (BP) [ Time Frame: Baseline, 16 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in Mean Orthostatic Blood Pressure (BP)
Measure Description	Supine BP was recorded after 5 minutes lying down; subjects then sat for 2 minutes then stood for 2 minutes and standing BP was recorded. Orthostatic BP = either a systolic BP drop > 20 mmHg, or diastolic BP drop > 10 mmHg and/or drop in systolic BP < 90 mmHg. If a subject met the orthostatic criteria, they were required to complete 2 additional readings to provide a triplicate reading. The means of replicate BP values were used in the analysis. Baseline = the latest non-missing value from a range of pre-treatment visits. Change from baseline to Week 16 was analyzed for orthostatic BP.
Time Frame	Baseline, 16 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Maraviroc 150 mg BID (PK)	150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (PK)	300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 150 mg BID (PK)	Maraviroc 300 mg BID (PK)	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	8	8	77	33
Change From Baseline in Mean Orthostatic Blood Pressure (BP) [units: mmHg] Mean ± Standard Deviation
Standing Systolic BP	20.9 ± 13.18	18.0 ± 7.71	17.8 ± 11.25	17.5 ± 12.36
Supine Systolic BP	20.9 ± 13.58	18.3 ± 9.51	17.5 ± 13.86	18.0 ± 11.12
Standing Diastolic BP	13.0 ± 4.97	8.3 ± 5.65	11.7 ± 6.98	11.5 ± 5.15
Supine Diastolic BP	10.3 ± 7.94	10.9 ± 5.08	12.2 ± 8.14	10.8 ± 5.12

No statistical analysis provided for Change From Baseline in Mean Orthostatic Blood Pressure (BP)

14. Secondary:

Change From Baseline in Mean Heart Rate [ Time Frame: Baseline, 16 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in Mean Heart Rate
Measure Description	Heart rate = standing and supine at the same time the orthostatic BP measurements were obtained. Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were not used.
Time Frame	Baseline, 16 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Maraviroc 150 mg BID (PK)	150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (PK)	300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 150 mg BID (PK)	Maraviroc 300 mg BID (PK)	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	8	8	77	33
Change From Baseline in Mean Heart Rate [units: beats per minute (bpm)] Mean ± Standard Deviation
Standing Heart Rate	14.6 ± 6.73	8.1 ± 3.64	11.8 ± 6.91	11.4 ± 8.13
Supine Heart Rate	15.0 ± 8.28	10.4 ± 4.56	11.6 ± 6.06	9.2 ± 6.16

No statistical analysis provided for Change From Baseline in Mean Heart Rate

15. Secondary:

Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline [ Time Frame: Baseline, 16 weeks ]

Measure Type	Secondary
Measure Title	Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline
Measure Description	Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Maximum increase from baseline in supine and standing systolic BP was > = 30 mmHg, and maximum increase from baseline in supine and standing diastolic BP was > = 20 mmHg.
Time Frame	Baseline, 16 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Maraviroc 150 mg BID (PK)	150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (PK)	300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 150 mg BID (PK)	Maraviroc 300 mg BID (PK)	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	8	8	77	33
Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline [units: Participants]
Maximum Increase in Supine Systolic BP	2	1	4	3
Maximum Increase in Standing Systolic BP	1	1	2	2
Maximum Increase in Supine Diastolic BP	1	1	8	0
Maximum Increase in Standing Diastolic BP	0	0	3	2

No statistical analysis provided for Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline

16. Secondary:

Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]). [ Time Frame: Baseline, 16 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).
Measure Description	Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used. QTc interval was not measured for the PK populations.
Time Frame	Baseline, 16 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Maraviroc 150 mg BID (PK)	150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (PK)	300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 150 mg BID (PK)	Maraviroc 300 mg BID (PK)	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	8	8	77	33
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]). [units: msec] Mean ± Standard Deviation
RR Interval	137.0 ± 79.18	114.3 ± 63.38	140.0 ± 70.81	117.6 ± 48.26
PR Interval	19.7 ± 7.13	13.0 ± 6.93	16.2 ± 8.00	15.4 ± 10.47
QRS Complex	7.6 ± 4.75	7.3 ± 4.89	11.3 ± 6.56	10.2 ± 5.35
QT Interval	35.0 ± 19.47	22.5 ± 10.67	31.9 ± 18.74	28.7 ± 13.97
QTc Interval	0 ± 0	0 ± 0	19.6 ± 17.69	20.3 ± 12.75
QTcB Interval	23.1 ± 19.70	23.3 ± 9.55	27.9 ± 18.47	30.2 ± 23.88
QTcF Interval	22.9 ± 19.64	17.3 ± 7.16	28.3 ± 18.77	29.8 ± 22.20

No statistical analysis provided for Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).

17. Secondary:

Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate). [ Time Frame: Baseline, 16 weeks ]

Measure Type	Secondary
Measure Title	Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate).
Measure Description	Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used.
Time Frame	Baseline, 16 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Maraviroc 150 mg BID (PK)	150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (PK)	300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 150 mg BID (PK)	Maraviroc 300 mg BID (PK)	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	8	8	77	33
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate). [units: bpm] Mean ± Standard Deviation	11.2 ± 5.82	8.8 ± 5.76	12.0 ± 6.40	10.5 ± 4.91

No statistical analysis provided for Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate).

18. Secondary:

Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline [ Time Frame: Baseline, 16 weeks ]

Measure Type	Secondary
Measure Title	Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Measure Description	Maximum QTcB, QTcF, and QTc intervals were defined as 450 to < 480 msec, 480 to < 500 msec, or > = 500 msec.
Time Frame	Baseline, 16 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Maraviroc 150 mg BID (PK)	150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (PK)	300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 150 mg BID (PK)	Maraviroc 300 mg BID (PK)	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	8	8	77	33
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline [units: Participants]
Maximum QTc Interval 450 to < 480 msec	0	0	2	2
Maximum QTc Interval 480 to < 500 msec	0	0	0	0
Maximum QTc Interval > = 500 msec	0	0	0	0
Maximum QTcB Interval 450 to < 480 msec	1	3	13	8
Maximum QTcB Interval 480 to < 500 msec	0	0	2	1
Maximum QTcB Interval > = 500 msec	0	0	0	1
Maximum QTcF Interval 450 to < 480 msec	0	2	9	5
Maximum QTcF Interval 480 to < 500 msec	0	0	0	0
Maximum QTcF Interval > = 500 msec	0	0	0	0

No statistical analysis provided for Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline

19. Secondary:

Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12 [ Time Frame: Baseline, Weeks 4 and 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12
Measure Description	The SF-36 v.2 (Acute version) is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (physical component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.
Time Frame	Baseline, Weeks 4 and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	69	30
Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12 [units: scores on a scale] Least Squares Mean ± Standard Error
Week 4	4.33 ± 0.89	3.76 ± 1.25
Week 12	3.14 ± 1.04	4.81 ± 1.65

Statistical Analysis 1 for Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.698
Mean Difference (Final Values) ^[4]	0.57
90% Confidence Interval	( -1.87 to 3.01 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.344
Mean Difference (Final Values) ^[4]	-1.68
90% Confidence Interval	( -4.62 to 1.26 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

20. Secondary:

Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12 [ Time Frame: Baseline, Weeks 4 and 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12
Measure Description	The SF-36 v.2 (Acute version) [12] is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (mental component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.
Time Frame	Baseline, Weeks 4 and 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	69	30
Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12 [units: scores on a scale] Least Squares Mean ± Standard Error
Week 4	1.42 ± 1.25	0.72 ± 1.75
Week 12	1.17 ± 1.41	0.61 ± 2.25

Statistical Analysis 1 for Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.734
Mean Difference (Final Values) ^[4]	0.70
90% Confidence Interval	( -2.71 to 4.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 4
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.818
Mean Difference (Final Values) ^[4]	0.56
90% Confidence Interval	( -3.50 to 4.62 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Week 12
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.
[4]	Other relevant estimation information:
	No text entered.

21. Secondary:

Number of Subjects With Withdrawal From Study Due to Lack of Efficacy [ Time Frame: 16 weeks ]

Measure Type	Secondary
Measure Title	Number of Subjects With Withdrawal From Study Due to Lack of Efficacy
Measure Description	Withdrawal is the total number of withdrawals from the study. Withdrawal due to lack of efficacy was collected based on the investigator’s judgement.
Time Frame	16 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	77	33
Number of Subjects With Withdrawal From Study Due to Lack of Efficacy [units: participants]
Overall Withdrawal	22	14
Withdrawal due to Lack of Efficacy	5	2

Statistical Analysis 1 for Number of Subjects With Withdrawal From Study Due to Lack of Efficacy

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.649

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

22. Secondary:

Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy. [ Time Frame: Weeks 1 to 12 ]

Measure Type	Secondary
Measure Title	Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.
Measure Description	Withdrawal due to lack of efficacy was collected based on the investigator’s judgement. Time to withdrawal was measured by the probability that a subject did not withdraw due to lack of efficacy by a particular visit. This was a statistical estimate (Kaplan-Meier Survival Analysis) of the probability that a participant would not withdraw due to lack of efficacy.
Time Frame	Weeks 1 to 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS

Reporting Groups

	Description
Maraviroc 300 mg BID (POC)	300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
Placebo (POC)	Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 300 mg BID (POC)	Placebo (POC)
Number of Participants Analyzed [units: participants]	77	33
Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy. [units: proportion]
Week 1 (n=77, 33)	1.00	1.00
Week 2 (n=77, 32)	1.00	1.00
Week 4 (n=76, 32)	1.00	1.00
Week 8 (n=69, 31)	0.99	1.00
Week 12 (n=58, 21)	0.93	0.92

Statistical Analysis 1 for Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.

Groups ^[1]	All groups
Method ^[2]	Log Rank
P Value ^[3]	0.9826

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

23. Secondary:

Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1 [ Time Frame: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose) ]

Measure Type	Secondary
Measure Title	Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1
Measure Description	Effect of maraviroc on the PK of MTX (comparison of AUC0-4 of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).
Time Frame	Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All available PK data from the Safety/PK Component were included.

Reporting Groups

	Description
Maraviroc 150 mg BID (PK)	150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (PK)	300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 150 mg BID (PK)	Maraviroc 300 mg BID (PK)
Number of Participants Analyzed [units: participants]	8	8
Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1 [units: ng.hr/mL] Geometric Mean ± Standard Deviation
Plasma MTX (Screening)	909.4 ± 422.37	888.9 ± 249.51
Plasma MTX (Week 1)	1045.6 ± 329.93	844.8 ± 273.92
Plasma Maraviroc (Week 1)	451.6 ± 247.33	1106.8 ± 1029.60

No statistical analysis provided for Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1

24. Secondary:

Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1 [ Time Frame: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose) ]

Measure Type	Secondary
Measure Title	Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1
Measure Description	Effect of maraviroc on the PK of MTX (comparison of Cmax of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).
Time Frame	Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All available PK data from the Safety/PK Component were included.

Reporting Groups

	Description
Maraviroc 150 mg BID (PK)	150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (PK)	300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 150 mg BID (PK)	Maraviroc 300 mg BID (PK)
Number of Participants Analyzed [units: participants]	8	8
Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1 [units: ng/mL] Geometric Mean ± Standard Deviation
Plasma MTX (Screening)	338.7 ± 143.94	352.1 ± 115.72
Plasma MTX (Week 1)	403.8 ± 97.46	322.8 ± 104.20
Plasma Maraviroc (Week 1)	199.59 ± 115.603	461.03 ± 365.715

No statistical analysis provided for Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1

25. Secondary:

Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1 [ Time Frame: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose) ]

Measure Type	Secondary
Measure Title	Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1
Measure Description	PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).
Time Frame	Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All available PK data from the Safety/PK Component were included.

Reporting Groups

	Description
Maraviroc 150 mg BID (PK)	150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
Maraviroc 300 mg BID (PK)	300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.

Measured Values

	Maraviroc 150 mg BID (PK)	Maraviroc 300 mg BID (PK)
Number of Participants Analyzed [units: participants]	8	8
Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1 [units: hr] Median ( Full Range )
Plasma MTX (Screening)	2.000 ( 1.00 to 3.00 )	1.000 ( 1.00 to 3.00 )
Plasma MTX (Week 1)	1.000 ( 0.50 to 2.00 )	1.500 ( 0.50 to 2.00 )
Plasma Maraviroc (Week 1)	2.000 ( 0.50 to 3.00 )	2.500 ( 1.00 to 4.00 )

No statistical analysis provided for Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided by ViiV Healthcare

Publications automatically indexed to this study:

Fleishaker DL, Garcia Meijide JA, Petrov A, Kohen MD, Wang X, Menon S, Stock TC, Mebus CA, Goodrich JM, Mayer HB, Zeiher BG. Maraviroc, a chemokine receptor-5 antagonist, fails to demonstrate efficacy in the treatment of patients with rheumatoid arthritis in a randomized, double-blind placebo-controlled trial. Arthritis Res Ther. 2012 Jan 17;14(1):R11.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier:	NCT00427934 History of Changes
Other Study ID Numbers:	A4001056
Study First Received:	January 25, 2007
Results First Received:	October 6, 2009
Last Updated:	November 10, 2010
Health Authority:	United States: Food and Drug Administration

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