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Trial With HuMax-CD4 in Patients With Rheumatoid Arthritis Failing Treatment With Methotrexate and a TNF-Alpha Blocker
This study has been completed.
First Received: July 29, 2002   Last Updated: June 23, 2005   History of Changes
Sponsored by: Genmab
Information provided by: Genmab
ClinicalTrials.gov Identifier: NCT00042406
  Purpose

The purpose of this study is to determine whether HuMax-CD4 is effective in the treatment of active rheumatoid arthritis in patients who have failed treatment with Methotrexate and at least one TNF-alpha blocking agent.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: HuMax-CD4
Phase II
Phase III

MedlinePlus related topics: Rheumatoid Arthritis
Drug Information available for: Methotrexate Zanolimumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Parallel Group Clinical Trial of Anti-CD4 Receptor Human Monoclonal Antibody (HuMax-CD4) in Patients With Active RA Failing Treatment With Methotrexate and TNF-Alpha Blocking Agents

Further study details as provided by Genmab:

Detailed Description:

This is a multi-center, double-blind, placebo-controlled, parallel-group, randomized trial of HuMax-CD4 in the treatment of patients with active rheumatoid arthritis (RA) who have failed treatment with Methotrexate (MTX) and at least one TNF-alpha blocking agent. Patients are randomized to receive one of two doses of HuMax-CD4 or placebo. The drug will be administered as a subcutaneous infusion (given just under the skin), more often in the beginning and then followed by a maintenance dose. There is a 4 week follow up period, and the final evaluation of the clinical endpoints takes place 26 weeks after treatment start. The trial lasts about 28 weeks in all.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of rheumatoid arthritis according to the American College of Rheumatology 1987 revised criteria (ACR) of at least 6 months duration.
  • Active disease at the time of screening.
  • Unable to tolerate Methotrexate, or lack of efficacy after a minimum of 6 months treatment.
  • Failure to tolerate treatment with either Enbrel or Remicade, or lack of efficacy after at least 3 months treatment with one of these agents.

Exclusion Criteria:

  • Active autoimmune disease requiring therapy (other than rheumatoid arthritis and secondary Sjögren’s disease).
  • The use of certain treatments or drugs for treatment of rheumatoid arthritis within 4 weeks of participation in the trial.
  • Syndromes such as Fibromyalgia which require chronic pain treatment.
  • Most past or current cancers.
  • Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest, nasal or throat infections, tuberculosis, hepatitis B and C.
  • History of infected joint prosthesis within 5 years.
  • Most active medical conditions such as heart disease, kidney disease, liver disease, blood diseases, hormonal disturbances, lung disease, psychiatric disease.
  • Drug or alcohol abuse.
  • Pregnant or breast-feeding women may not participate. Women of childbearing potential must use either contraceptive pills or an intra-uterine device for the entire study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042406

  Show 54 Study Locations
Sponsors and Collaborators
Genmab
  More Information

No publications provided

Study ID Numbers: Hx-CD4-004
Study First Received: July 29, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00042406     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antimetabolites
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adrenergic alpha-Antagonists
Folic Acid Antagonists
Immunosuppressive Agents
Folic Acid
Antibodies, Monoclonal
Antibodies
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Antirheumatic Agents
Immunoglobulins

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 06, 2009