Working... Menu

Trial With HuMax-CD4 in Patients With Rheumatoid Arthritis Failing Treatment With Methotrexate and a TNF-alpha Blocker

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00042406
Recruitment Status : Terminated
First Posted : August 1, 2002
Last Update Posted : December 7, 2012
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: HuMax-CD4 Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2002
Actual Primary Completion Date : September 2002

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Experimental: HuMax-CD4 80 mg
80 mg
Drug: HuMax-CD4
Experimental: HuMax-CD4 160 mg
160 mg
Drug: HuMax-CD4

Primary Outcome Measures :
  1. ACR20 [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00042406

  Show 54 Study Locations
Sponsors and Collaborators
Emergent Product Development Seattle LLC

Layout table for additonal information
Responsible Party: Emergent Product Development Seattle LLC Identifier: NCT00042406     History of Changes
Other Study ID Numbers: Hx-CD4-004
First Posted: August 1, 2002    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012

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