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

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HuMax-CD4
Placebo
Humax-CD4
Sponsored by
Genmab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rheumatology Associates
  • Pro Health Partners, Inc.
  • Rheumatology & Internal Medicine, Boling Clinical Trials
  • Advances in Medicine
  • Radiant Research, Inc.
  • West Coast Clinical Research
  • Arthritis Center of CT
  • Arthritis Associates of South Florida
  • Ocala Rheumatology Research Center
  • nTouch Research
  • Radiant Research, Inc.
  • Tampa Medical Group Research
  • nTouch Research
  • North Western Center for Clinical Research
  • Rheumatology Associates, P.C.
  • Advocate Medical Group
  • The Arthritis Center
  • Deerbrook Medical Associates
  • West Pharmaceutical Services
  • Idaho Arthritis & Osteoporosis Center
  • Mercy Arthritis Center
  • University of Louisville Hospital
  • Osteoporosis and Clinical Trials Center
  • Beth Israel Deaconess Medical Center
  • Arthritis Education and Treatment Center
  • Midwest Arthritis Center
  • Fiechtner Research
  • Westroads Medical Group
  • Arthritis Center of Reno
  • One Crouse Medical Plaza
  • C.A.R.E. Center
  • DataPharm, Inc.
  • Disease Study Group / Deaconess Hospital
  • Lynn Health Science
  • Bend Memorial Clinic
  • Rheumatology Clinic
  • Providence Arthritis Center
  • Northwest Rheumatology Associates, PC
  • East Pennsylvania Rheumatology
  • Altoona Arthritis & Osteoporosis Center
  • Clinical Research Center of Reading
  • Presbyterian Hospital of Dallas
  • IHC Clinical Research Foundation
  • Medical College of Virginia, Div. of Rheum.
  • Lewis Gayle Clinic
  • Evergreen Medical & Dental Center
  • South Puget Sound Clinical Research Center
  • Minor & James Med., First Hill Medical Building
  • Internal Medicine Association of Yakima, Inc., P.S.
  • Medical Arts Center
  • CIADS, Medical Arts Building
  • Ottawa Hospital-General Campus
  • Sunnybrook/Women's College Research Health Science Center
  • Institute de Rhumtologie de Montreal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

HuMax-CD4 80 milligrams (mg)

HuMax-CD4 160 mg

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants with American College of Rheumatology (ACR) 20 Response
Change from Baseline in Disease Activity Score (DAS)
Change from Baseline in SFP-36 questionnaire at Week 10 and 26
Change from Baseline in C-Reactive Protein (CRP)
Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
Number of Participants with Adverse Events (AEs)

Secondary Outcome Measures

Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Number of Participants With Clinically Significant Laboratory Abnormalities

Full Information

First Posted
July 29, 2002
Last Updated
April 26, 2023
Sponsor
Genmab
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1. Study Identification

Unique Protocol Identification Number
NCT00042406
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Study Start Date
March 4, 2002 (Actual)
Primary Completion Date
March 31, 2003 (Actual)
Study Completion Date
March 31, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
HuMax-CD4 80 milligrams (mg)
Arm Type
Experimental
Arm Title
HuMax-CD4 160 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HuMax-CD4
Other Intervention Name(s)
Zanolimumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was administered as a subcutaneous infusion twice (BID) with 2 weeks interval followed by administration every 4 weeks up to Week 22.
Intervention Type
Drug
Intervention Name(s)
Humax-CD4
Other Intervention Name(s)
Zanolimumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants with American College of Rheumatology (ACR) 20 Response
Time Frame
At Week 14 and Week 18
Title
Change from Baseline in Disease Activity Score (DAS)
Time Frame
Baseline up to Week 26
Title
Change from Baseline in SFP-36 questionnaire at Week 10 and 26
Time Frame
Baseline, Week 10 and Week 26
Title
Change from Baseline in C-Reactive Protein (CRP)
Time Frame
Baseline up to Week 26
Title
Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
Time Frame
Baseline up to Week 26
Title
Number of Participants with Adverse Events (AEs)
Time Frame
Day 1 up to end of study (Week 26)
Secondary Outcome Measure Information:
Title
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Time Frame
Up to 26 weeks
Title
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame
Up to 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rheumatology Associates
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111-2654
Country
United States
Facility Name
Pro Health Partners, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90813-3412
Country
United States
Facility Name
Rheumatology & Internal Medicine, Boling Clinical Trials
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Advances in Medicine
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Radiant Research, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
West Coast Clinical Research
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
Arthritis Center of CT
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Arthritis Associates of South Florida
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Ocala Rheumatology Research Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
nTouch Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Radiant Research, Inc.
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
Tampa Medical Group Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
nTouch Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
North Western Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rheumatology Associates, P.C.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Advocate Medical Group
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
The Arthritis Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Deerbrook Medical Associates
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
West Pharmaceutical Services
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Idaho Arthritis & Osteoporosis Center
City
Meridian Hills
State/Province
Indiana
ZIP/Postal Code
83642
Country
United States
Facility Name
Mercy Arthritis Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50322
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Osteoporosis and Clinical Trials Center
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Arthritis Education and Treatment Center
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Midwest Arthritis Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
Fiechtner Research
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Westroads Medical Group
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Arthritis Center of Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
One Crouse Medical Plaza
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
C.A.R.E. Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
DataPharm, Inc.
City
Canfield
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
Facility Name
Disease Study Group / Deaconess Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Lynn Health Science
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Rheumatology Clinic
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Providence Arthritis Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Northwest Rheumatology Associates, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
East Pennsylvania Rheumatology
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Arthritis & Osteoporosis Center
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635-0909
Country
United States
Facility Name
Clinical Research Center of Reading
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
IHC Clinical Research Foundation
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Medical College of Virginia, Div. of Rheum.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0647
Country
United States
Facility Name
Lewis Gayle Clinic
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Evergreen Medical & Dental Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
South Puget Sound Clinical Research Center
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Minor & James Med., First Hill Medical Building
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Internal Medicine Association of Yakima, Inc., P.S.
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Medical Arts Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
CIADS, Medical Arts Building
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 3J5
Country
Canada
Facility Name
Ottawa Hospital-General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook/Women's College Research Health Science Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Institute de Rhumtologie de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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