Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis
RITAM
Post Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid Arthritis
1 other identifier
observational
130
1 country
4
Brief Summary
This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective study will examine the efficacy and safety of rituximab in participants who had previously received rituximab in terms of everyday medical practice. Efficacy and safety of rituximab will be determined 24 weeks after receiving the first infusion, 24 weeks after the second infusion repeated courses of treatment (if the participants receive another course of rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the participants receive third course of rituximab). Protocol does not specify the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab will be administered at the discretion of treating physician according to approved label.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2007
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedResults Posted
Study results publicly available
October 26, 2016
CompletedOctober 26, 2016
September 1, 2016
6.3 years
February 25, 2016
September 2, 2016
September 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion
DAS28 score is a measure of participant's disease activity calculated using tender joint count \[28 joints\] (TJC28), swollen joint count \[28 joints\] (SJC28), participant's global assessment of disease activity (PGH) \[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: \[0.56 multiplied by (\*) square root (√) of TJC\] plus (+) \[0.28\*√SJC\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*PGH\]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (\</=) 3.2 indicated low disease activity, score of greater than (\>) 3.2 to \</=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease.
Baseline, 24 weeks after first rituximab infusion (Week 24)
Secondary Outcomes (1)
Percentage of Participants With European League Against Rheumatism (EULAR) Good Response
Baseline, Weeks 24, 48 and 72
Study Arms (1)
Rheumatoid arthritis participants
Participants who were on rituximab for rheumatoid arthritis and who will continue receiving rituximab treatment (at the discretion of treating physician) according to previous approved indication will be observed for a period of 72 weeks.
Interventions
Rituximab will be administered at the discretion of treating physician according to approved label. Protocol does not specify/enforce the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab.
Eligibility Criteria
Participants receiving rituximab no longer than 4 weeks for the treatment of rheumatoid arthritis before the start of study.
You may qualify if:
- Participants receiving rituximab no longer than 4 weeks before the start of monitoring
You may not qualify if:
- Not Applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Belgrade, 11000, Serbia
Unknown Facility
Niška Banja, 18250, Serbia
Unknown Facility
Nova Sad, 21000, Serbia
Unknown Facility
Novi Sad, 21000, Serbia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2016
First Posted
March 4, 2016
Study Start
October 1, 2007
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
October 26, 2016
Results First Posted
October 26, 2016
Record last verified: 2016-09