An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNF Therapy (REPEAT)

Rheumatoid Arthritis Clinical Trial

Official title:

MabThera Post Marketing Observational Study in TNF-IR Patients to Assess Efficacy and Safety of REPeated Courses in routinE ClinicAl pracTice

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01196780
• Other study ID #: ML25228
• Status: Terminated
• Phase: N/A
• First received: September 6, 2010
• Last updated: November 1, 2016
• Start date: February 2010
• Est. completion date: October 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines and Medical Devices Agency (NMMDA)
• Study type: Observational

Clinical Trial Summary

This observational study will assess the efficacy and safety of MabThera/Rituxan (Rituximab) in patients with active rheumatoid arthritis who have had an inadequate response or are intolerant to anti-TNF therapy. Data will be collected from patients initiated on MabThera/Rituxan therapy according to standard of care in routine clinical practice. For each patient data will be collected for 92 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1240
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Active Rheumatoid Arthritis

• Inadequate response to anti-TNF

• Eligible for MabThera/Rituxan therapy according to physician's decision

Exclusion Criteria:

• According to Summary of Product Characteristics

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Change in Disease Activity Score - erythrocyte sedimentation rate (DAS28 - ESR)		from baseline to Week 92	No
Secondary	Safety: Incidence of adverse events		4 years	No