Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00413660

First received: December 18, 2006

Last updated: January 14, 2013

Last verified: January 2013

History of Changes

Results First Received: December 4, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Arthritis, Rheumatoid
Interventions:	Drug: CP-690,550 Other: 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
CP-690,550 1 mg	CP-690,550 1 milligram (mg) tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 3 mg	CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 5 mg	CP-690,550 5 mg tablet orally twice daily for 24 weeks.
CP-690,550 10 mg	CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg	CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg	CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Placebo	Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 1 mg to CP-690,550 5 mg (R)	Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 3 mg to CP-690,550 5 mg (R)	Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
CP-690,550 20 mg to CP-690,550 5 mg (R)	Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Placebo to CP-690,550 5 mg (R)	Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.

Participant Flow for 2 periods

Period 1: Up To Week 12

	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	CP-690,550 20 mg	Placebo
STARTED	71	68	71	75	75	80	69
Treated	70	68	71	74	75	80	69
COMPLETED	64	61	64	67	66	70	58
NOT COMPLETED	7	7	7	8	9	10	11
Adverse Event	1	3	1	4	6	4	1
Lack of Efficacy	2	0	0	0	0	0	5
Lost to Follow-up	0	1	0	0	1	0	0
Withdrawal by Subject	0	2	0	2	0	2	2
Randomized, Not Treated	1	0	0	1	0	0	0
Unspecified	3	1	6	1	2	4	3

Period 2: Post Week 12

	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	CP-690,550 20 mg	Placebo	CP-690,550 1 mg to CP-690,550 5 mg (R)	CP-690,550 3 mg to CP-690,550 5 mg (R)	CP-690,550 20 mg to CP-690,550 5 mg (R)	Placebo to CP-690,550 5 mg (R)
STARTED	43	48	64	67	66	57	40	21	13	13	18
COMPLETED	40	44	56	66	60	54	37	21	13	12	17
NOT COMPLETED	3	4	8	1	6	3	3	0	0	1	1
Adverse Event	2	0	2	1	4	2	2	0	0	0	0
Lack of Efficacy	0	0	1	0	0	0	0	0	0	1	0
Lost to Follow-up	0	1	1	0	0	0	0	0	0	0	0
Withdrawal by Subject	0	1	1	0	1	0	0	0	0	0	1
Unspecified	1	2	3	0	1	1	1	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
CP-690,550 1 mg	CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 3 mg	CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
CP-690,550 5 mg	CP-690,550 5 mg tablet orally twice daily for 24 weeks.
CP-690,550 10 mg	CP-690,550 10 mg tablet orally twice daily for 24 weeks.
CP-690,550 15 mg	CP-690,550 15 mg tablet orally twice daily for 24 weeks.
CP-690,550 20 mg	CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
Placebo	Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
Total	Total of all reporting groups

Baseline Measures

	CP-690,550 1 mg	CP-690,550 3 mg	CP-690,550 5 mg	CP-690,550 10 mg	CP-690,550 15 mg	CP-690,550 20 mg	Placebo	Total
Number of Participants [units: participants]	70	68	71	74	75	80	69	507
Age, Customized [units: participants]
18 to 44 Years	15	23	19	9	14	15	17	112
45 to 64 Years	47	31	42	49	49	49	40	307
Greater Than or Equal to (>=) 65 Years	8	14	10	16	12	16	12	88
Gender [units: participants]
Female	57	52	57	55	66	63	56	406
Male	13	16	14	19	9	17	13	101

Outcome Measures

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1. Primary:

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Week 12 ]

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2. Secondary:

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response [ Time Frame: Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET) ]

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3. Secondary:

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 3

4. Secondary:

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 4

5. Secondary:

Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve [ Time Frame: Baseline up to Week 2, 4, 6, 8, 12 ]

Show Outcome Measure 5

6. Secondary:

Tender Joints Count (TJC) [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 6

7. Secondary:

Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 7

8. Secondary:

Swollen Joints Count (SJC) [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 8

9. Secondary:

Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 9

10. Secondary:

Patient Assessment of Arthritis Pain [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 10

11. Secondary:

Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 11

12. Secondary:

Patient Global Assessment (PtGA) of Arthritis [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 12

13. Secondary:

Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 13

14. Secondary:

Physician Global Assessment of Arthritis [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 14

15. Secondary:

Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

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16. Secondary:

Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 16

17. Secondary:

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 17

18. Secondary:

C-Reactive Protein (CRP) [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 18

19. Secondary:

Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 19

20. Secondary:

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 20

21. Secondary:

Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 21

22. Secondary:

Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 22

23. Secondary:

Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ]

Show Outcome Measure 23

24. Secondary:

36-Item Short-Form Health Survey (SF-36) [ Time Frame: Baseline, Week 12, 24/ET ]

Show Outcome Measure 24

25. Secondary:

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET [ Time Frame: Baseline, Week 12, 24/ET ]

Show Outcome Measure 25

26. Secondary:

Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score [ Time Frame: Baseline, Week 12, 24/ET ]

Show Outcome Measure 26

27. Secondary:

Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET [ Time Frame: Baseline, Week 12, 24/ET ]

Show Outcome Measure 27

28. Secondary:

Medical Outcome Study- Sleep Scale (MOS-SS) [ Time Frame: Baseline, Week 2, 12, 24/ET ]

Show Outcome Measure 28

29. Secondary:

Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET [ Time Frame: Baseline, Week 2, 12, 24/ET ]

Show Outcome Measure 29

30. Secondary:

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale [ Time Frame: Baseline, Week 2, 12, 24/ET ]

Show Outcome Measure 30

31. Secondary:

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET [ Time Frame: Baseline, Week 2, 12, 24/ET ]

Show Outcome Measure 31

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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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
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Results Point of Contact:

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

No publications provided by Pfizer

Publications automatically indexed to this study:

Kremer JM, Cohen S, Wilkinson BE, Connell CA, French JL, Gomez-Reino J, Gruben D, Kanik KS, Krishnaswami S, Pascual-Ramos V, Wallenstein G, Zwillich SH. A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone. Arthritis Rheum. 2012 Apr;64(4):970-81. doi: 10.1002/art.33419. Epub 2011 Oct 17.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00413660 History of Changes
Other Study ID Numbers:	A3921025
Study First Received:	December 18, 2006
Results First Received:	December 4, 2012
Last Updated:	January 14, 2013
Health Authority:	United States: Food and Drug Administration

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