A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201

June 14, 2016 updated by: Biogen
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of natalizumab in subjects with active rheumatoid arthritis (RA) receiving concomitant methotrexate (MTX)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

Subjects will be eligible to begin study participation if they meet all of the following inclusion criteria:

  • Subjects must give written informed consent
  • Male or female subjects ≥18 to ≤75 years of age (at randomization in Study ELN100226-RA201)
  • Subjects must have been randomized in Study ELN100226-RA201;
  • Subjects who have completed the Month 6 visit of Study ELN100226-RA201 OR Subjects who have an inadequate therapeutic response (defined as a < 20% reduction from baseline [Month 0 in Study ELN100226-RA201] for both painful/tender and swollen joint counts) after receiving at least 4 infusions of study drug and has not been rescued with other RA medications during the treatment phase of Study ELN100226-RA201;
  • Subjects must be taking MTX at the same dose last used in Study ELN100226-RA201;
  • Female subjects of childbearing potential agreed to use adequate, contraceptive methods (either intrauterine device [IUD], oral or depot contraceptive, or barrier plus spermicide). Female subjects of childbearing potential used adequate contraception for at least 2 months prior to study entry and continued contraception for at least 3 months after their last infusion of study drug;
  • Subjects must be willing and able to complete all planned study procedures.

EXCLUSION CRITERIA

Subjects will be excluded from the study if they meet any of the following exclusion criteria:

  • Females who are pregnant or breastfeeding or those planning to become pregnant in the next 14 months;
  • Subjects who have experienced anaphylaxis, angioedema, urticaria, clinical syndrome diagnostic of serum sickness, or biopsy-proven vasculitis to a previous infusion of study drug;
  • Subjects who received rescue intervention in Study ELN100226-RA201, defined as an increase in dose of an existing permitted concomitant treatment of RA or the introduction of a new treatment of RA;
  • Subject who are expected to be unavailable for the duration of the trial, likely to be noncompliant with the Protocol, or who are felt to be unsuitable by the Investigator for any other reason;
  • Subjects with a history of a malignancy (other than surgically excised basal or squamous cell carcinoma of the skin);
  • Subjects with 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 places the subject at unacceptable risk for participation in the study;
  • Subjects who intend to donate blood or blood products during the period of the study or within one month following completion of the study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: natalizumab
Drug: natalizumab
Other Names:
  • TYSABRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The number and proportion of subjects with AEs
The number and proportion of subjects with SAEs
The number and percentage of subjects who discontinue early from the study due to an AE
Assessment of clinical laboratory parameters, physical examination, and vital signs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Elan Pharmaceuticals

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

September 1, 2004

Primary Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 29, 2009

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELN100226-RA251

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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