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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02699892
Other study ID # ML21619
Secondary ID
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


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
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