A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

Rheumatoid Arthritis Clinical Trial

Official title:

An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576433
• Other study ID #: ML21271
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2007
• Last updated: November 1, 2016
• Start date: December 2007
• Est. completion date: November 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Federal Agency of Drug Quality Control
• Study type: Interventional

Clinical Trial Summary

This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-80 years of age;

• moderate to severe active rheumatoid arthritis;

• inadequate response to previous or current treatment with 1 anti-TNF agent;

• receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for >=4 weeks.

Exclusion Criteria:

• previous treatment with MabThera;

• use of an anti-TNF alpha agent within 8 weeks of study start;

• concurrent treatment with any DMARD other than methotrexate;

• active infection, or history of serious recurrent or chronic infection.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Methotrexate
As prescribed
• rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs, including infusion-related adverse events		For 48 weeks after initial treatment	No
Secondary	Safety of re-treatment (AEs)		For 24 weeks after re-treatment.	No
Secondary	Laboratory parameters, vital signs.		Throughout study	No
Secondary	ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.		For 48 weeks after initial treatment.	No