A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

July 7, 2017 updated by: Hoffmann-La Roche

An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate

In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is <50

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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

  • Tunisia
      • Sousse, Tunisia, 4000
        • Hopital Farhat Hached; Service Rhumatologie
      • Tunis, Tunisia, 1006
        • Hopital Charles Nicole; Service Rhumatologie
      • Tunis, Tunisia, 1007
        • Hopital La Rabta; Service Rhumatologie
      • Tunis, Tunisia, 2046
        • Hopital Mongi Slim; Service Rhumatologie

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients >/= 18 years of age
  • rheumatoid arthritis DAS28 >/= 3.2
  • receiving treatment on an outpatient basis
  • experienced an inadequate response to previous or current treatment with methotrexate

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
  • history of or current inflammatory joint disease other than RA
  • previous treatment with any cell-depleting therapies

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: single arm
Drug: rituximab [MabThera/Rituxan]
1000 mg iv infusion on days 1 and 15
Drug: methotrexate
10-25 mg weekly (oral or parenteral)
Drug: methylprednisolone
100 mg iv prior to each rituximab infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Reporting Adverse Events (AEs)
Time Frame: Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks
Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24
Time Frame: Baseline and Week 24
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation.
Baseline and Week 24
Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24
Time Frame: Baseline and Week 24
The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement.
Baseline and Week 24
Change in Bone Density (in Participants Untreated With Bisphosphonates)
Time Frame: Screening and Week 84
Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis.
Screening and Week 84

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 (ACTUAL)

March 17, 2008

Primary Completion (ACTUAL)

May 16, 2012

Study Completion (ACTUAL)

May 16, 2012

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (ESTIMATE)

October 23, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2017

Last Update Submitted That Met QC Criteria

July 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20549

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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