An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor

Rheumatoid Arthritis Clinical Trial

Official title:

A Global Multi-centre Observational Study in RA Patients Who Are Non Responders or Intolerant to a Single TNF Inhibitor.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557348
• Other study ID #: MA22401
• Status: Completed
• Phase: N/A
• First received: March 13, 2012
• Last updated: March 4, 2013
• Start date: April 2009
• Est. completion date: November 2012

Study information

• Verified date: March 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1219
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant to a single TNF-inhibitor therapy

• Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy, in accordance with the relevant Summary of Product Characteristics

Exclusion Criteria:

• Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment

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

Countries where clinical trial is conducted

Canada,  Colombia,  France,  Germany,  Greece,  Italy,  Mexico,  Monaco,  Norway,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) 6 months after change in biologic therapy		approximately 14 years	No
Secondary	Mean change in DAS28-ESR 12 months after change in biologic therapy		approximately 14 years	No
Secondary	Mean change in tender/swollen joint count (TJC/SJC) at 6 and 12 months		approximately 14 years	No
Secondary	Safety: Incidence of adverse events		approximately 14 years	No
Secondary	Mean change in C-reactive protein at 6 and 12 months		approximately 14 years	No
Secondary	Quality of life: Health assessment questionnaires (HAQ)		approximately 14 years	No
Secondary	Proportion of patients remaining on their second biologic therapy at 6 and 12 months after starting		approximately 14 years	No