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

April 26, 2023 updated by: Genmab

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 3J5
        • CIADS, Medical Arts Building
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital-General Campus
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook/Women's College Research Health Science Center
    • Quebec
      • Montreal, Quebec, Canada, H2L 1S6
        • Institute de Rhumtologie de Montreal
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36111-2654
        • Rheumatology Associates
    • California
      • Long Beach, California, United States, 90813-3412
        • Pro Health Partners, Inc.
      • Rancho Cucamonga, California, United States, 91730
        • Rheumatology & Internal Medicine, Boling Clinical Trials
      • Rancho Mirage, California, United States, 92270
        • Advances in Medicine
      • San Diego, California, United States, 92108
        • Radiant Research, Inc.
      • Van Nuys, California, United States, 91405
        • West Coast Clinical Research
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Arthritis Center of CT
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Arthritis Associates of South Florida
      • Ocala, Florida, United States, 34474
        • Ocala Rheumatology Research Center
      • Saint Petersburg, Florida, United States, 33707
        • nTouch Research
      • Stuart, Florida, United States, 34996
        • Radiant Research, Inc.
      • Tampa, Florida, United States, 33614
        • Tampa Medical Group Research
    • Georgia
      • Decatur, Georgia, United States, 30033
        • nTouch Research
    • Illinois
      • Chicago, Illinois, United States, 60611
        • North Western Center for Clinical Research
      • Chicago, Illinois, United States, 60612
        • Rheumatology Associates, P.C.
      • Park Ridge, Illinois, United States, 60068
        • Advocate Medical Group
      • Springfield, Illinois, United States, 62704
        • The Arthritis Center
      • Vernon Hills, Illinois, United States, 60061
        • Deerbrook Medical Associates
    • Indiana
      • Evansville, Indiana, United States, 47714
        • West Pharmaceutical Services
      • Meridian Hills, Indiana, United States, 83642
        • Idaho Arthritis & Osteoporosis Center
    • Iowa
      • Des Moines, Iowa, United States, 50322
        • Mercy Arthritis Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Osteoporosis and Clinical Trials Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Arthritis Education and Treatment Center
      • Kalamazoo, Michigan, United States, 49001
        • Midwest Arthritis Center
      • Lansing, Michigan, United States, 48910
        • Fiechtner Research
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Westroads Medical Group
    • Nevada
      • Reno, Nevada, United States, 89502
        • Arthritis Center of Reno
    • New York
      • Syracuse, New York, United States, 13210
        • One Crouse Medical Plaza
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • C.A.R.E. Center
    • Ohio
      • Canfield, Ohio, United States, 44406
        • DataPharm, Inc.
      • Cincinnati, Ohio, United States, 45219
        • Disease Study Group / Deaconess Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
      • Medford, Oregon, United States, 97504
        • Rheumatology Clinic
      • Portland, Oregon, United States, 97213
        • Providence Arthritis Center
      • Portland, Oregon, United States, 97225
        • Northwest Rheumatology Associates, PC
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • East Pennsylvania Rheumatology
      • Duncansville, Pennsylvania, United States, 16635-0909
        • Altoona Arthritis & Osteoporosis Center
      • West Reading, Pennsylvania, United States, 19611
        • Clinical Research Center of Reading
    • Texas
      • Dallas, Texas, United States, 75231
        • Presbyterian Hospital of Dallas
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • IHC Clinical Research Foundation
    • Virginia
      • Richmond, Virginia, United States, 23298-0647
        • Medical College of Virginia, Div. of Rheum.
      • Salem, Virginia, United States, 24153
        • Lewis Gayle Clinic
    • Washington
      • Kirkland, Washington, United States, 98034
        • Evergreen Medical & Dental Center
      • Olympia, Washington, United States, 98502
        • South Puget Sound Clinical Research Center
      • Seattle, Washington, United States, 98104
        • Minor & James Med., First Hill Medical Building
      • Yakima, Washington, United States, 98902
        • Internal Medicine Association of Yakima, Inc., P.S.
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Medical Arts Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo was administered as a subcutaneous infusion twice (BID) with 2 weeks interval followed by administration every 4 weeks up to Week 22.
Experimental: HuMax-CD4 80 milligrams (mg)
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.
Other Names:
  • Zanolimumab
Experimental: HuMax-CD4 160 mg
Drug: 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.
Other Names:
  • Zanolimumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with American College of Rheumatology (ACR) 20 Response
Time Frame: At Week 14 and Week 18
At Week 14 and Week 18
Change from Baseline in Disease Activity Score (DAS)
Time Frame: Baseline up to Week 26
Baseline up to Week 26
Change from Baseline in SFP-36 questionnaire at Week 10 and 26
Time Frame: Baseline, Week 10 and Week 26
Baseline, Week 10 and Week 26
Change from Baseline in C-Reactive Protein (CRP)
Time Frame: Baseline up to Week 26
Baseline up to Week 26
Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
Time Frame: Baseline up to Week 26
Baseline up to Week 26
Number of Participants with Adverse Events (AEs)
Time Frame: Day 1 up to end of study (Week 26)
Day 1 up to end of study (Week 26)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Time Frame: Up to 26 weeks
Up to 26 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: Up to 26 weeks
Up to 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genmab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2002

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Hx-CD4-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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