Clinical trial NCT00042406: Trial With HuMax-CD4 in Participants With Rheumatoid Arthritis (RA) Failing Treatment With Methotrexate (MTX) and a TNF-alpha Blocker
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 Rheumatoid Arthritis Failing Treatment With Methotrexate and TNF-alpha Blocking Agents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Genmab
Sponsor class: INDUSTRY
First posted: 2002-08-01
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether HuMax-CD4 is effective in the treatment of active RA in participants who have failed treatment with MTX and at least one TNF-alpha blocking agent.

Detailed description: This is a multi-center, double-blind, placebo-controlled, parallel-group, randomized trial of HuMax-CD4 in the treatment of participants with active RA who have failed treatment with MTX and at least one TNF-alpha blocking agent. Participants 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 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.
* Failure to tolerate MTX, or lack of efficacy after a minimum of 6 months treatment with MTX.

Exclusion Criteria:

* Active autoimmune disease requiring therapy (other than rheumatoid arthritis and secondary Sjögren's disease).
* 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.

Note: Other protocol defined Inclusion and Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants with American College of Rheumatology (ACR) 20 Response
timeFrame: At Week 14 and Week 18
measure: Change from Baseline in Disease Activity Score (DAS)
timeFrame: Baseline up to Week 26
measure: Change from Baseline in SFP-36 questionnaire at Week 10 and 26
timeFrame: Baseline, Week 10 and Week 26
measure: Change from Baseline in C-Reactive Protein (CRP)
timeFrame: Baseline up to Week 26
measure: Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline up to Week 26
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Day 1 up to end of study (Week 26)
Secondary outcomes:
measure: Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
timeFrame: Up to 26 weeks
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Up to 26 weeks
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Rheumatology Associates
state: Alabama
city: Long Beach
country: United States
facility: Pro Health Partners, Inc.
state: California
city: Rancho Cucamonga
country: United States
facility: Rheumatology & Internal Medicine, Boling Clinical Trials
state: California
city: Rancho Mirage
country: United States
facility: Advances in Medicine
state: California
city: San Diego
country: United States
facility: Radiant Research, Inc.
state: California
city: Van Nuys
country: United States
facility: West Coast Clinical Research
state: California
city: Waterbury
country: United States
facility: Arthritis Center of CT
state: Connecticut
city: Delray Beach
country: United States
facility: Arthritis Associates of South Florida
state: Florida
city: Ocala
country: United States
facility: Ocala Rheumatology Research Center
state: Florida
city: Saint Petersburg
country: United States
facility: nTouch Research
state: Florida
city: Stuart
country: United States
facility: Radiant Research, Inc.
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group Research
state: Florida
city: Decatur
country: United States
facility: nTouch Research
state: Georgia
city: Chicago
country: United States
facility: North Western Center for Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Rheumatology Associates, P.C.
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Medical Group
state: Illinois
city: Springfield
country: United States
facility: The Arthritis Center
state: Illinois
city: Vernon Hills
country: United States
facility: Deerbrook Medical Associates
state: Illinois
city: Evansville
country: United States
facility: West Pharmaceutical Services
state: Indiana
city: Meridian Hills
country: United States
facility: Idaho Arthritis & Osteoporosis Center
state: Indiana
city: Des Moines
country: United States
facility: Mercy Arthritis Center
state: Iowa
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Hagerstown
country: United States
facility: Osteoporosis and Clinical Trials Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Arthritis Education and Treatment Center
state: Michigan
city: Kalamazoo
country: United States
facility: Midwest Arthritis Center
state: Michigan
city: Lansing
country: United States
facility: Fiechtner Research
state: Michigan
city: Omaha
country: United States
facility: Westroads Medical Group
state: Nebraska
city: Reno
country: United States
facility: Arthritis Center of Reno
state: Nevada
city: Syracuse
country: United States
facility: One Crouse Medical Plaza
state: New York
city: Raleigh
country: United States
facility: C.A.R.E. Center
state: North Carolina
city: Canfield
country: United States
facility: DataPharm, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Disease Study Group / Deaconess Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science
state: Oklahoma
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Medford
country: United States
facility: Rheumatology Clinic
state: Oregon
city: Portland
country: United States
facility: Providence Arthritis Center
state: Oregon
city: Portland
country: United States
facility: Northwest Rheumatology Associates, PC
state: Oregon
city: Bethlehem
country: United States
facility: East Pennsylvania Rheumatology
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Arthritis & Osteoporosis Center
state: Pennsylvania
city: West Reading
country: United States
facility: Clinical Research Center of Reading
state: Pennsylvania
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas
state: Texas
city: Salt Lake City
country: United States
facility: IHC Clinical Research Foundation
state: Utah
city: Richmond
country: United States
facility: Medical College of Virginia, Div. of Rheum.
state: Virginia
city: Salem
country: United States
facility: Lewis Gayle Clinic
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Medical & Dental Center
state: Washington
city: Olympia
country: United States
facility: South Puget Sound Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Minor & James Med., First Hill Medical Building
state: Washington
city: Yakima
country: United States
facility: Internal Medicine Association of Yakima, Inc., P.S.
state: Washington
city: Milwaukee
country: United States
facility: Medical Arts Center
state: Wisconsin
city: Winnipeg
country: Canada
facility: CIADS, Medical Arts Building
state: Manitoba
city: Ottawa
country: Canada
facility: Ottawa Hospital-General Campus
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook/Women's College Research Health Science Center
state: Ontario
city: Montreal
country: Canada
facility: Institute de Rhumtologie de Montreal
state: Quebec
Study officials:
References: