Study Stopped
The biological effect seen with natalizumab was not sufficient to warrant further development in RA.
Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
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)
1 other identifier
interventional
299
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
12 active sites
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
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 1, 2004
CompletedFirst Posted
Study publicly available on registry
June 3, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedResults Posted
Study results publicly available
June 2, 2009
CompletedJuly 18, 2016
April 1, 2009
9 months
June 1, 2004
January 27, 2009
July 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
American College of Rheumatology (ACR)20.
≥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)
Month 6
Secondary Outcomes (2)
American College of Rheumatology (ACR)50
Month 6
American College of Rheumatology (ACR)70
Month 6
Study Arms (2)
natalizumab
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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);
- Treatment with any TNF-alpha inhibitor within 2 months prior to randomization (Month 0);
- Subject who is expected to be unavailable for the duration of the trial, likely to be noncompliant with the Protocol, or felt to be unsuitable by the Investigator for any other reason;
- Subject who has a history of a malignancy (other than basal cell carcinoma of the skin);
- Subject who has a history of clinically significant and/or persistent gastrointestinal, pulmonary, chronic infection, cardiovascular, renal, hepatic, neurological, dermatological, immunological, major psychiatric (including drug or alcohol abusers) or hematological illness, which, in the opinion of the Investigator placed the subject at unacceptable risk for participation in the study;
- Subject who has any laboratory test at Screening considered significantly abnormal. An alanine transaminase (ALT) or aspartate transaminase (AST) ≥1.5 x upper limits of normal (ULN) and cytopenia (included any of the following: WBC \<3.5 x 1000/uL; hemoglobin \[Hb\] \<8 g/dL; platelets \<100 x 1000/uL; and/or neutrophils absolute \<1.0 x 1000/uL) were considered significantly abnormal;
- Subject who intends to donate blood or blood products during the period of the study or within 1 month following completion of the study;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
- Elan Pharmaceuticalscollaborator
Study Sites (12)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Clinical Research Unit / University of Arizona
Tucson, Arizona, 85719, United States
Arthritis Medical Clinic of North County, Inc.
Escondido, California, 92025-4402, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Massachusetts General Hospital
Boston, Maine, 02114, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Justus Fiechtner, MD, PC
Lansing, Michigan, 48910, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090, United States
Radiant Research
Dallas, Texas, 75235, United States
St. Clare's Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
The Arthritis Program Research Group Inc.
Newmarket, Ontario, L3Y 3R7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated prematurely on 28 February 2005. The biological effect seen with natalizumab was not sufficient to warrant further development in RA.
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2004
First Posted
June 3, 2004
Study Start
May 1, 2004
Primary Completion
February 1, 2005
Last Updated
July 18, 2016
Results First Posted
June 2, 2009
Record last verified: 2009-04