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A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

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ClinicalTrials.gov Identifier: NCT01617005
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : December 1, 2016
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Intervention Drug: Tocilizumab
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tocilizumab in Moderate to Severe Active RA
Hide Arm/Group Description Moderate to severe active Rheumatoid Arthritis (RA) participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Period Title: Overall Study
Started 50
Completed 48
Not Completed 2
Reason Not Completed
Pregnancy             1
Lack of motivation for treatment             1
Arm/Group Title Tocilizumab in Moderate to Severe Active RA
Hide Arm/Group Description Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
All participants who were enrolled in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
51.9  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
41
  82.0%
Male
9
  18.0%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study.
Arm/Group Title Tocilizumab in Moderate to Severe Active RA
Hide Arm/Group Description:
Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
SAEs 0
AEs 38
2.Secondary Outcome
Title Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria
Hide Description EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study.
Arm/Group Title Tocilizumab in Moderate to Severe Active RA
Hide Arm/Group Description:
Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
EULAR Good Response 0
EULAR Moderate Response 40
3.Secondary Outcome
Title Number of Participants Who Discontinued Treatment Due to Lack of Efficacy
Hide Description [Not Specified]
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study.
Arm/Group Title Tocilizumab in Moderate to Severe Active RA
Hide Arm/Group Description:
Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
0
4.Secondary Outcome
Title Time to Discontinuation Due to Lack of Efficacy
Hide Description [Not Specified]
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
As none of the participants discontinued treatment due to lack of efficacy, this outcome measure was not estimable.
Arm/Group Title Tocilizumab in Moderate to Severe Active RA
Hide Arm/Group Description:
Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up to Week 24
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tocilizumab in Moderate to Severe Active RA
Hide Arm/Group Description Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
All-Cause Mortality
Tocilizumab in Moderate to Severe Active RA
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tocilizumab in Moderate to Severe Active RA
Affected / at Risk (%)
Total   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tocilizumab in Moderate to Severe Active RA
Affected / at Risk (%)
Total   38/50 (76.00%) 
Blood and lymphatic system disorders   
Pancytopenia * 1  2/50 (4.00%) 
Neutropenia * 1  15/50 (30.00%) 
Leukopenia with neutropenia * 1  8/50 (16.00%) 
Leukopenia * 1  2/50 (4.00%) 
Leukocytosis * 1  1/50 (2.00%) 
Thrombocytopenia * 1  2/50 (4.00%) 
Cardiac disorders   
Bradycardia * 1  1/50 (2.00%) 
Gastrointestinal disorders   
Gastralgia * 1  1/50 (2.00%) 
Abdominal pain * 1  1/50 (2.00%) 
Diarrhea * 1  1/50 (2.00%) 
Infections and infestations   
Oral herpes simplex * 1  1/50 (2.00%) 
Bronchopneumonia * 1  1/50 (2.00%) 
Cellulitis * 1  1/50 (2.00%) 
Fever * 1  1/50 (2.00%) 
Investigations   
Hepatic transaminases increased * 1  10/50 (20.00%) 
Metabolism and nutrition disorders   
Hypercholesterolemia with hypertriglyceridemia * 1  1/50 (2.00%) 
Hypercholesterolemia * 1  9/50 (18.00%) 
Musculoskeletal and connective tissue disorders   
Polyartralgia * 1  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/50 (2.00%) 
Vascular disorders   
Hypertension * 1  2/50 (4.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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 only after the first publication or presentation that involves the Overall Study. The 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
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01617005     History of Changes
Other Study ID Numbers: ML25699
First Submitted: June 8, 2012
First Posted: June 12, 2012
Results First Submitted: October 7, 2016
Results First Posted: December 1, 2016
Last Update Posted: December 1, 2016