BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis

September 12, 2013 updated by: Biogen

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis.

Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Research Centre
      • Yaroslavl, Russian Federation
        • Research Centre
  • United States
    • Alabama
      • Anniston, Alabama, United States
        • Research Site
    • California
      • Palm Desert, California, United States
        • Research Centre
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • Research Centre

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of adult onset RA (functional class I-III) for at least 6 months
  • Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks
  • Must have at least 4 swollen and tender joints due to rheumatoid arthritis

Exclusion Criteria:

  • History of recurrent infections requiring antibiotic treatment within 12 months
  • Serious local infection or systemic infection within 3 months
  • Suffering from rheumatic or autoimmune disease other than RA
  • History of cancer, heart failure, kidney disease, liver disease, HIV infection, tuberculosis or other serious illness

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Other: Placebo (sterile normal saline)
Single IV dose of Placebo
Experimental: 1
BIIB023
Drug: BIIB023
Single IV doses of BIIB023 in dose-escalating cohorts
Other Names:
  • Human glycosylated IgG1 monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.
Time Frame: Baseline through Day 70
Baseline through Day 70

Secondary Outcome Measures

Outcome Measure
Time Frame
• Estimate the pharmacokinetic (PK) parameters of single doses of BIIB023 administered IV to subjects with RA • Evaluate potential markers of pharmacodynamic (PD) action of BIIB023 and its biological effects
Time Frame: Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70
Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70

Collaborators and Investigators

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

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 10, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (Estimate)

October 13, 2008

Study Record Updates

Last Update Posted (Estimate)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211RA101

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.

Subscribe