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An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01741688
Recruitment Status : Completed
First Posted : December 5, 2012
Results First Posted : October 12, 2015
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Intervention Biological: Tocilizumab
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tocilizumab
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Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Period Title: Overall Study
Started 16
Completed 13
Not Completed 3
Reason Not Completed
Lack of insurance coverage             2
Withdrawal by Subject             1
Arm/Group Title Tocilizumab
Hide Arm/Group Description

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
55
(33.4 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
14
  87.5%
Male
2
  12.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Peru Number Analyzed 16 participants
16
1.Primary Outcome
Title Number of Participants on Tocilizumab at 6 Months After Treatment Initiation
Hide Description [Not Specified]
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
14
2.Secondary Outcome
Title Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis
Hide Description Systemic manifestation measured by C-reactive protein levels > 3
Time Frame At baseline
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
93.8
3.Secondary Outcome
Title Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure
Hide Description DMARDs exposure was evaluated for all participants. "Prior DMARDs treatment" includes participants, who were treated with DMARDs 6 months before being included in the study. "DMARDs treatment at baseline" includes participants, who were receiving DMARDs when they were included in the study and continued with this concomitant medication to tocilizumab.
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
Prior DMARDs treatment 18.8
DMARDs treatment at baseline 62.5
4.Secondary Outcome
Title Number of Participants Starting Tocilizumab After Failing Other Biologic Agents
Hide Description Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab
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Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
1
5.Secondary Outcome
Title Median Dose at 6 Months
Hide Description [Not Specified]
Time Frame At 6 months
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Hide Analysis Population Description
Number of participants remaining in the study at 6 months
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: mg/kg of body weight
8
(6.3 to 9.2)
6.Secondary Outcome
Title Number of Participants With Dose Modifications at 6 Months
Hide Description [Not Specified]
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab
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Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
4
7.Secondary Outcome
Title Median Duration of Treatment
Hide Description [Not Specified]
Time Frame Approximately 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: months
6
(3.4 to 6.8)
8.Secondary Outcome
Title Percentage of Participants Discontinued From Tocilizumab for Safety
Hide Description Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab.
Time Frame Approximately 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
0
9.Secondary Outcome
Title Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy
Hide Description Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician.
Time Frame Approximately 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
0
10.Secondary Outcome
Title Number of Participants Discontinued From Tocilizumab for Other Reasons
Hide Description This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment.
Time Frame Approximately 16 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
3
11.Secondary Outcome
Title Time to Restoration of Initial Dosing Regimen
Hide Description [Not Specified]
Time Frame Approximately 16 months
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Non-adherence Rate of Physician to the Recommended Dosing Regimen
Hide Description [Not Specified]
Time Frame Approximately 16 months
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Percentage of Participants on Tocilizumab Monotherapy at Study Entry
Hide Description [Not Specified]
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
12.5
14.Secondary Outcome
Title Total Tender Joint Count (TJC)
Hide Description [Not Specified]
Time Frame At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: Number of tender joints/participant
Visit 1
18
(12 to 22)
Observation 1
0
(0 to 5)
Observation 2
0
(0 to 6)
Observation 3
0
(0 to 0)
Observation 4
0
(0 to 0)
Observation 5
0
(0 to 0)
15.Secondary Outcome
Title Total Swollen Joint Count (SJC)
Hide Description [Not Specified]
Time Frame At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: Number of swollen joints/participant
Visit 1
18
(5 to 18)
Observation 1
0.5
(0 to 8)
Observation 2
0
(0 to 6)
Observation 3
0
(0 to 10)
Observation 4
0
(0 to 0)
Observation 5
0
(0 to 0)
16.Secondary Outcome
Title Disease Activity Score Based on 28 Joints (DAS28)
Hide Description

The DAS28 is a measure of disease activity in rheumatoid arthritis (RA) and the number 28 refers to the 28 joints that are examined in this assessment. To calculate the DAS28 the following assessments are done: 1) count the number of swollen joints (out of the 28 [sw28]), 2) count the number of tender joints (out of the 28 [t28]), 3) measure Erythrocyte Sedimentation Rate (ESR), and 4) ask the participant to make a 'global assessment of health' (GH) indicated by marking a 10 cm line between very good and very bad.

The Score is developed under the follow formula:

DAS28(4) = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH Where, t=tender joints; sw=swollen joints; ESR= Erythrocyte Sedimentation Rate; GH=Global assessment of health score.

This score may range from 0 to 9.3, where a DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.

Time Frame At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: DAS28 score
Visit 1
6.29
(4.82 to 6.72)
Observation 1
2.87
(1.89 to 3.67)
Observation 2
2.23
(2.02 to 3.38)
Observation 3
2.16
(1.82 to 2.80)
Observation 4
2.45
(2.45 to 2.45)
Observation 5
2.41
(2.41 to 2.41)
Time Frame From baseline to end of study, approximately 16 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tocilizumab
Hide Arm/Group Description

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Tocilizumab: Tocilizumab was administered according to the local label.

All-Cause Mortality
Tocilizumab
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Tocilizumab
Affected / at Risk (%) # Events
Total   1/16 (6.25%)    
Hepatobiliary disorders   
Cholelithiasis   1/16 (6.25%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tocilizumab
Affected / at Risk (%) # Events
Total   4/16 (25.00%)    
Eye disorders   
Keratitis   1/16 (6.25%)  1
Corneal ulcer   1/16 (6.25%)  1
Nervous system disorders   
Migraine   1/16 (6.25%)  1
Headache   1/16 (6.25%)  1
Renal and urinary disorders   
Urinary tract infection   1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Flu   1/16 (6.25%)  1
Indicates events were collected by systematic assessment
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 study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01741688    
Other Study ID Numbers: ML28206
First Submitted: November 30, 2012
First Posted: December 5, 2012
Results First Submitted: July 23, 2015
Results First Posted: October 12, 2015
Last Update Posted: August 1, 2017