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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Chelyabinsk, Russian Federation, 454076
      • Ekaterinburg, Russian Federation, 620102
      • Irkutsk, Russian Federation, 664047
      • Kazan, Russian Federation, 420012
      • Khabarovsk, Russian Federation, 680009
      • Khanty-Mansiysk, Russian Federation, 628011
      • Kursk, Russian Federation, 305007
      • Moscow, Russian Federation, 115522
      • Nizhny Novgorod, Russian Federation, 603126
      • Novosibirsk, Russian Federation, 630117
      • Novosibirsk, Russian Federation, 630099
      • Ryazan, Russian Federation, 390026
      • Saint-Petersburg, Russian Federation, 195067
      • Tjumen, Russian Federation, 625023
      • UFA, Russian Federation, 450005
      • Vladivostok, Russian Federation, 690050
      • Voronezh, Russian Federation, 394066
      • Yaroslavl, Russian Federation, 150062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
Drug: Methotrexate
As prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AEs, including infusion-related adverse events
Time Frame: For 48 weeks after initial treatment
For 48 weeks after initial treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of re-treatment (AEs)
Time Frame: For 24 weeks after re-treatment.
For 24 weeks after re-treatment.
Laboratory parameters, vital signs.
Time Frame: Throughout study
Throughout study
ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.
Time Frame: For 48 weeks after initial treatment.
For 48 weeks after initial treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 18, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21271

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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