An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Sero-Positive Rheumatoid Arthritis Who Are Non-Responders or Intolerant to a Single TNF-Inhibitor (PORTSMAB)

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01309282

ML22935

Details and patient eligibility

About

This observational study will assess the long-term efficacy and safety of MabThera/Rituxan in routine clinical practice in patients with sero-positive rheumatoid arthritis who are non-responders or intolerant to a single tumour necrosis factor (TNF) inhibitor. Data will be collected from each patient over 2 years.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Rheumatoid arthritis positive for rheumatoid factor and/or anti-CCP
• Non-responder or intolerant to single TNF-inhibitor therapy
• Initiating treatment with MabThera/Rituxan

Exclusion criteria

• Contra-indications to MabThera/Rituxan therapy

Trial design

9 participants in 1 patient group

Rituximab

Description:

Sero-positive \[Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (CCP+)\] rheumatoid arthritis (RA) patients, who had initiated therapy with Rituximab (MabThera) following lack of response or intolerance to a single tumour necrosis factor (TNF)-inhibitor will be included in this arm