Trial With HuMax-CD4 in Participants With Rheumatoid Arthritis (RA) Failing Treatment With Methotrexate (MTX) and a TNF-alpha Blocker

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00042406
• Other study ID #: Hx-CD4-004
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: March 4, 2002
• Est. completion date: March 31, 2003

Study information

• Verified date: April 2023
• Source: Genmab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: March 31, 2003
• Est. primary completion date: March 31, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• HuMax-CD4
HuMax-CD4 80 mg was administered as a subcutaneous infusion BID with 2 weeks interval followed by administration every 4 weeks up to Week 22.
• Placebo
Placebo was administered as a subcutaneous infusion twice (BID) with 2 weeks interval followed by administration every 4 weeks up to Week 22.
• Humax-CD4
HuMax-CD4 160 mg was administered as a subcutaneous infusion BID with 2 weeks interval followed by administration every 4 weeks up to Week 22.

Locations

Country	Name	City	State
Canada	Institute de Rhumtologie de Montreal	Montreal	Quebec
Canada	Ottawa Hospital-General Campus	Ottawa	Ontario
Canada	Sunnybrook/Women's College Research Health Science Center	Toronto	Ontario
Canada	CIADS, Medical Arts Building	Winnipeg	Manitoba
United States	Bend Memorial Clinic	Bend	Oregon
United States	East Pennsylvania Rheumatology	Bethlehem	Pennsylvania
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	DataPharm, Inc.	Canfield	Ohio
United States	North Western Center for Clinical Research	Chicago	Illinois
United States	Rheumatology Associates, P.C.	Chicago	Illinois
United States	Disease Study Group / Deaconess Hospital	Cincinnati	Ohio
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	nTouch Research	Decatur	Georgia
United States	Arthritis Associates of South Florida	Delray Beach	Florida
United States	Mercy Arthritis Center	Des Moines	Iowa
United States	Altoona Arthritis & Osteoporosis Center	Duncansville	Pennsylvania
United States	West Pharmaceutical Services	Evansville	Indiana
United States	Arthritis Education and Treatment Center	Grand Rapids	Michigan
United States	Osteoporosis and Clinical Trials Center	Hagerstown	Maryland
United States	Midwest Arthritis Center	Kalamazoo	Michigan
United States	Evergreen Medical & Dental Center	Kirkland	Washington
United States	Fiechtner Research	Lansing	Michigan
United States	Pro Health Partners, Inc.	Long Beach	California
United States	University of Louisville Hospital	Louisville	Kentucky
United States	Rheumatology Clinic	Medford	Oregon
United States	Idaho Arthritis & Osteoporosis Center	Meridian Hills	Indiana
United States	Medical Arts Center	Milwaukee	Wisconsin
United States	Rheumatology Associates	Montgomery	Alabama
United States	Ocala Rheumatology Research Center	Ocala	Florida
United States	Lynn Health Science	Oklahoma City	Oklahoma
United States	South Puget Sound Clinical Research Center	Olympia	Washington
United States	Westroads Medical Group	Omaha	Nebraska
United States	Advocate Medical Group	Park Ridge	Illinois
United States	Northwest Rheumatology Associates, PC	Portland	Oregon
United States	Providence Arthritis Center	Portland	Oregon
United States	C.A.R.E. Center	Raleigh	North Carolina
United States	Rheumatology & Internal Medicine, Boling Clinical Trials	Rancho Cucamonga	California
United States	Advances in Medicine	Rancho Mirage	California
United States	Arthritis Center of Reno	Reno	Nevada
United States	Medical College of Virginia, Div. of Rheum.	Richmond	Virginia
United States	nTouch Research	Saint Petersburg	Florida
United States	Lewis Gayle Clinic	Salem	Virginia
United States	IHC Clinical Research Foundation	Salt Lake City	Utah
United States	Radiant Research, Inc.	San Diego	California
United States	Minor & James Med., First Hill Medical Building	Seattle	Washington
United States	The Arthritis Center	Springfield	Illinois
United States	Radiant Research, Inc.	Stuart	Florida
United States	One Crouse Medical Plaza	Syracuse	New York
United States	Tampa Medical Group Research	Tampa	Florida
United States	West Coast Clinical Research	Van Nuys	California
United States	Deerbrook Medical Associates	Vernon Hills	Illinois
United States	Arthritis Center of CT	Waterbury	Connecticut
United States	Clinical Research Center of Reading	West Reading	Pennsylvania
United States	Internal Medicine Association of Yakima, Inc., P.S.	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Genmab

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with American College of Rheumatology (ACR) 20 Response		At Week 14 and Week 18
Primary	Change from Baseline in Disease Activity Score (DAS)		Baseline up to Week 26
Primary	Change from Baseline in SFP-36 questionnaire at Week 10 and 26		Baseline, Week 10 and Week 26
Primary	Change from Baseline in C-Reactive Protein (CRP)		Baseline up to Week 26
Primary	Change from Baseline in Erythrocyte Sedimentation Rate (ESR)		Baseline up to Week 26
Primary	Number of Participants with Adverse Events (AEs)		Day 1 up to end of study (Week 26)
Secondary	Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres		Up to 26 weeks
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities		Up to 26 weeks