Study to Evaluate Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Post Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699892
• Other study ID #: ML21619
• Status: Completed
• Phase: N/A
• First received: February 25, 2016
• Last updated: March 1, 2016
• Start date: October 2007
• Est. completion date: February 2014

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Agency for Medicines and Medical Devices
• Study type: Observational

Clinical Trial Summary

This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective study will evaluate the efficacy and safety of rituximab in the treatment of rheumatoid arthritis 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 first infusion repeated courses of treatment (if the participants receive another course of rituximab) and 24 weeks after the first infusion repeated courses of treatment (if the participants receive third course of rituximab).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

-Participants receiving rituximab longer than 4 weeks before the start of monitoring

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Rituximab
Participants will receive rituximab as per investigator discretion according to approved indication.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants achieving reduction in disease activity score based on 28 joints count (DAS28) of more than 1.2 units after 24 weeks of first rituximab infusion		24 weeks	No
Secondary	Number of participants with European League Against Rheumatism (EULAR) response		24 and 48 weeks	No
Secondary	Number of participants with adverse events		Baseline up to end of the study (approximately 74 months 22 days)	No