An Observational Study of Rituximab in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Non-interventional Multicenter Study of MabThera® (Rituximab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283399
• Other study ID #: ML25270
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: November 1, 2016
• Start date: August 2010
• Est. completion date: April 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Ministry of Public Health
• Study type: Observational

Clinical Trial Summary

This observational study will assess the efficacy and safety of combination of rituximab (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA) who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in routine clinical practice. Data will be collected from participants for 12 months after the first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Active rheumatoid arthritis

• Inadequate response to a single TNF inhibitor

• Participants receiving rituximab therapy in accordance with the prescribing information

• Signed data release form within 6 weeks (42 days) of initiating rituximab therapy

• Women of childbearing potential must use effective form of contraception

Exclusion Criteria:

• Contra-indication to receive rituximab according to the local labelling

• Previous treatment with rituximab

• Treatment with any investigational drug within 30 days prior to enrolment

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

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score Based on 28-joints Count (DAS28)		Up to 5 years	No
Secondary	Reasons for Re-treatment With Rituximab Within 6 Months of the First Treatment		Up to 5 years	No
Secondary	Disease Activity Score Based on 28-joints Count (DAS28) 6 Months After the Re-treatment With Rituximab		6 Months After the Re-treatment With Rituximab (up to 5 years)	No
Secondary	Demographics of Participants Eligible to Receive Rituximab		Baseline	No
Secondary	Number of Participants With Adverse Events		5 years	No