Text Size

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:
NCT00042406
First received: July 29, 2002
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emergent Product Development Seattle LLC:

Primary Outcome Measures:
  • ACR20 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Experimental: HuMax-CD4 80 mg
80 mg
 Drug: HuMax-CD4
Experimental: HuMax-CD4 160 mg
160 mg
 Drug: HuMax-CD4

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
Emergent Product Development Seattle LLC
  More Information

No publications provided

Responsible Party: Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier: NCT00042406     History of Changes
Other Study ID Numbers: Hx-CD4-004
Study First Received: July 29, 2002
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013