A Phase II, Multicenter, Double-blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Natalizumab (300 mg) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Receiving Concomitant Treatment With Methotrexate (MTX)

Biogen12 sites in 2 countries299 target enrollmentMay 2004

ConditionsRheumatoid Arthritis

Interventionsnatalizumab placebo

Drugsnatalizumab placebo

Overview

Phase: Phase 2
Intervention: natalizumab
Conditions: Rheumatoid Arthritis
Sponsor: Biogen
Enrollment: 299
Locations: 12
Primary Endpoint: American College of Rheumatology (ACR)20.
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety, tolerability and efficacy of natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis (RA) receiving concomitant treatment with methotrexate (MTX). It is thought that natalizumab may stop the movement of certain white blood cells, known as lymphocytes, into joint tissue. These cells are thought to cause damage in the joints leading to the symptoms of RA.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

February 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects will be eligible to begin study participation if they meet all of the following inclusion criteria:
•Subject is able to read, understand, and voluntarily sign the approved Informed Consent form prior to the performance of any study-specific procedures;
•Male or female subjects, ≥18 to ≤75 years of age, who has a diagnosis of rheumatoid arthritis Functional Class 1 to 3 by the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis for at least 6 months prior to screening;
•Subject is on a stable dose of MTX of at least 10 mg/week for ≥3 months prior to randomization (Month 0) without an adequate response;
•Female subjects of childbearing potential agree to use adequate, contraceptive methods (either intrauterine device \[IUD\], oral or depot contraceptive, or barrier plus spermicide). Female subjects of childbearing potential use adequate contraception for at least 2 months prior to study entry and continue contraception for at least 3 months after their last infusion of study drug;
•Subject is willing and able to complete all planned study procedures;
•Subject has at least 10 painful/tender and 6 swollen joints at the Month 0 (Baseline) visit;
•Subject has an elevated CRP level (defined as \>2.87 mg/L) at Screening.

Exclusion Criteria

•Subjects will be excluded from the study if they meet any of the following exclusion criteria:
•Subject is pregnant or lactating;
•Subject who has experienced an inadequate therapeutic response after at least 3 months of treatment with at least one TNF-alpha inhibitor;
•Subject who has received treatment with anakinra;
•Subject who has received prior treatment with natalizumab;
•Subject does not meet the following criteria regarding concomitant medications for RA:
•Use of any oral steroid exceeding 10 mg/day of prednisone (or equivalent dose) and not administered at a stable dose for at least 1 month prior to randomization (Month 0);
•Use of any NSAIDs unless stable for at least 1 month prior to randomization (Month 0);
•Use of other anti-arthritic treatments, including approved or experimental oral, topical, or injectable biologics or drugs, or devices within 1 month prior to randomization (Month 0);
•Intra-articular corticosteroid injections within 1 month prior to randomization (Month 0);

Arms & Interventions

natalizumab

Intervention: natalizumab

placebo

Intervention: placebo

Outcomes

Primary Outcomes

American College of Rheumatology (ACR)20.

Time Frame: Month 6

≥20% reduction from baseline in painful/tender joint count and swollen joint count and ≥20% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)