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

July 29, 2002
December 5, 2012
September 2002
September 2002   (final data collection date for primary outcome measure)
ACR20 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00042406 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Not Provided
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Trial With HuMax-CD4 in Patients With Rheumatoid Arthritis Failing Treatment With Methotrexate and a TNF-alpha Blocker
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: HuMax-CD4
  • Placebo Comparator: Placebo
  • Experimental: HuMax-CD4 80 mg
    80 mg
    Intervention: Drug: HuMax-CD4
  • Experimental: HuMax-CD4 160 mg
    160 mg
    Intervention: Drug: HuMax-CD4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
75
Not Provided
September 2002   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00042406
Hx-CD4-004
Not Provided
Emergent Product Development Seattle LLC
Emergent Product Development Seattle LLC
Not Provided
Not Provided
Emergent Product Development Seattle LLC
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP