Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis (RITAM)

• ClinicalTrials.gov Identifier: NCT02699892
• Recruitment Status: Completed
• First Posted: March 4, 2016
• Results First Posted: October 26, 2016
• Last Update Posted: October 26, 2016
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment
Rheumatoid Arthritis	Drug: Rituximab

Study Design

• Study Type: Observational
• Actual Enrollment: 130 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid Arthritis
• Study Start Date: October 2007
• Actual Primary Completion Date: February 2014
• Actual Study Completion Date: February 2014

Groups and Cohorts

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 Name: MabThera

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: Baseline, 24 weeks after first rituximab infusion (Week 24) ]
   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.

Secondary Outcome Measures :

1. Percentage of Participants With European League Against Rheumatism (EULAR) Good Response [ Time Frame: Baseline, Weeks 24, 48 and 72 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-Not Applicable

Contacts and Locations

Locations

Serbia

Belgrade, Serbia, 11000

Niska Banja, Serbia, 18250

Nova sad, Serbia, 21000

Novi Sad, Serbia, 21000

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02699892
• Other Study ID Numbers: ML21619
• First Posted: March 4, 2016
• Results First Posted: October 26, 2016
• Last Update Posted: October 26, 2016
• Last Verified: September 2016

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Rituximab; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents