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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Rituximab

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
  • Niska Banja, Serbia, 18250
  • Nova sad, Serbia, 21000
  • Novi Sad, Serbia, 21000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants receiving rituximab no longer than 4 weeks for the treatment of rheumatoid arthritis before the start of study.

Description

Inclusion Criteria:

-Participants receiving rituximab no longer than 4 weeks before the start of monitoring

Exclusion Criteria:

-Not Applicable

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Rituximab; 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.; Other Names: MabThera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With European League Against Rheumatism (EULAR) Good Response	Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Weeks 24, 48, and 72. EULAR response was based on change from baseline (CFB) in DAS28 score and on actual DAS28 score, at Weeks 24, 48, and 72. DAS28 score: participant's disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated by following formula: (0.56*√TJC)+(0.28*√SJC)+(0.70*ln ESR)+(0.014*PGH). Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28</=3.2; reduction of DAS28 >1.2.	Baseline, Weeks 24, 48 and 72

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: September 2, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: ML21619