NCT00074438

Brief Summary

This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
465

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_2 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 9, 2013

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

December 12, 2003

Last Update Submit

May 7, 2013

Conditions

Rheumatoid Arthritis

Keywords

RituxanRA

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with an ACR20 response

    24 weeks

Secondary Outcomes (2)

  • Proportion of patients with ACR(50,70) responses

    24 weeks

  • Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups

    24 weeks

Study Arms (9)

1

EXPERIMENTAL
Drug: methotrexateDrug: rituximab

2

EXPERIMENTAL
Drug: methotrexateDrug: rituximabDrug: corticosteroids

3

EXPERIMENTAL
Drug: methotrexateDrug: rituximabDrug: corticosteroids

4

EXPERIMENTAL
Drug: methotrexateDrug: rituximab

5

EXPERIMENTAL
Drug: methotrexateDrug: rituximabDrug: corticosteroids

6

EXPERIMENTAL
Drug: methotrexateDrug: rituximabDrug: corticosteroids

7

PLACEBO COMPARATOR
Drug: methotrexateDrug: placebo

8

PLACEBO COMPARATOR
Drug: methotrexateDrug: corticosteroidsDrug: placebo

9

PLACEBO COMPARATOR
Drug: methotrexateDrug: corticosteroidsDrug: placebo

Interventions

methotrexateDRUG

Oral or parenteral repeating dose

123456789
rituximabDRUG

Intravenous repeating dose

123456
corticosteroidsDRUG

Intravenous repeating dose

235689
placeboDRUG

Intravenous repeating dose

789

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Eligibility criteria include, but are not limited to the following: * Are between the ages of 18 and 80 years. * Have been diagnosed with rheumatoid arthritis for at least 6 months. * Have failed treatment (lack of efficacy) with at least 1 but no more than 5 disease-modifying anti-rheumatic drugs or biologics (other than methotrexate).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, Dougados M, Baldassare A, Ferraccioli G, Chubick A, Udell J, Cravets MW, Agarwal S, Cooper S, Magrini F. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007 Dec;56(12):3896-908. doi: 10.1002/art.23059.

    PMID: 18050221DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

MethotrexateRituximabAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2003

First Posted

December 15, 2003

Study Start

June 1, 2003

Primary Completion

September 1, 2004

Study Completion

July 1, 2011

Last Updated

May 9, 2013

Record last verified: 2013-05