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Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate

Information source: Elan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: natalizumab (Drug); placebo (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Elan Pharmaceuticals


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.

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: American College of Rheumatology (ACR)20.

Secondary outcome:

American College of Rheumatology (ACR)50

American College of Rheumatology (ACR)70


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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)


- 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


- 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


- 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


- 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


- 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;

- Subject who has a positive tuberculosis (TB) skin test at Screening or within the 30

days prior to Screening (defined as ≥10 mm induration);

- Subject who plans or requires any surgical procedure during the study treatment


Locations and Contacts

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

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

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

Additional Information

Starting date: May 2004
Last updated: June 1, 2009

Page last updated: August 23, 2015

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