Rheumatoid ArthritisPhase 2/3NCT00042406
Trial With HuMax-CD4 in Participants With Rheumatoid Arthritis (RA) Failing Treatment With Methotrexate (MTX) and a TNF-alpha Blocker
A Phase 2/3 study testing HuMax-CD4 in people with Rheumatoid Arthritis, run by Genmab at 54 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- HuMax-CD4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 54 sitesin 2 countries
- Study dates
- 4 Mar 2002to 31 Mar 2003
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
54 sites in 2 countries.
54 sites in 2 countries
United States50 sites
Bend Memorial Clinic
Bend, Oregon, 97701
East Pennsylvania Rheumatology
Bethlehem, Pennsylvania, 18015
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
DataPharm, Inc.
Canfield, Ohio, 44406
North Western Center for Clinical Research
Chicago, Illinois, 60611
Rheumatology Associates, P.C.
Chicago, Illinois, 60612
Disease Study Group / Deaconess Hospital
Cincinnati, Ohio, 45219
Presbyterian Hospital of Dallas
Dallas, Texas, 75231
nTouch Research
Decatur, Georgia, 30033
Arthritis Associates of South Florida
Delray Beach, Florida, 33484
Mercy Arthritis Center
Des Moines, Iowa, 50322
Altoona Arthritis & Osteoporosis Center
Duncansville, Pennsylvania, 16635-0909
West Pharmaceutical Services
Evansville, Indiana, 47714
Arthritis Education and Treatment Center
Grand Rapids, Michigan, 49503
Osteoporosis and Clinical Trials Center
Hagerstown, Maryland, 21740
Midwest Arthritis Center
Kalamazoo, Michigan, 49001
Evergreen Medical & Dental Center
Kirkland, Washington, 98034
Fiechtner Research
Lansing, Michigan, 48910
Pro Health Partners, Inc.
Long Beach, California, 90813-3412
University of Louisville Hospital
Louisville, Kentucky, 40202
Rheumatology Clinic
Medford, Oregon, 97504
Idaho Arthritis & Osteoporosis Center
Meridian Hills, Indiana, 83642
Medical Arts Center
Milwaukee, Wisconsin, 53211
Rheumatology Associates
Montgomery, Alabama, 36111-2654
Ocala Rheumatology Research Center
Ocala, Florida, 34474
Lynn Health Science
Oklahoma City, Oklahoma, 73112
South Puget Sound Clinical Research Center
Olympia, Washington, 98502
Westroads Medical Group
Omaha, Nebraska, 68114
Advocate Medical Group
Park Ridge, Illinois, 60068
Providence Arthritis Center
Portland, Oregon, 97213
Northwest Rheumatology Associates, PC
Portland, Oregon, 97225
C.A.R.E. Center
Raleigh, North Carolina, 27609
Rheumatology & Internal Medicine, Boling Clinical Trials
Rancho Cucamonga, California, 91730
Advances in Medicine
Rancho Mirage, California, 92270
Arthritis Center of Reno
Reno, Nevada, 89502
Medical College of Virginia, Div. of Rheum.
Richmond, Virginia, 23298-0647
Lewis Gayle Clinic
Salem, Virginia, 24153
IHC Clinical Research Foundation
Salt Lake City, Utah, 84102
Radiant Research, Inc.
San Diego, California, 92108
Minor & James Med., First Hill Medical Building
Seattle, Washington, 98104
The Arthritis Center
Springfield, Illinois, 62704
nTouch Research
St. Petersburg, Florida, 33707
Radiant Research, Inc.
Stuart, Florida, 34996
One Crouse Medical Plaza
Syracuse, New York, 13210
Tampa Medical Group Research
Tampa, Florida, 33614
West Coast Clinical Research
Van Nuys, California, 91405
Deerbrook Medical Associates
Vernon Hills, Illinois, 60061
Arthritis Center of CT
Waterbury, Connecticut, 06708
Clinical Research Center of Reading
West Reading, Pennsylvania, 19611
Internal Medicine Association of Yakima, Inc., P.S.
Yakima, Washington, 98902
Canada4 sites
Institute de Rhumtologie de Montreal
Montreal, Quebec, H2L 1S6
Ottawa Hospital-General Campus
Ottawa, Ontario, K1H 8L6
Sunnybrook/Women's College Research Health Science Center
Toronto, Ontario, M4N 3M5
CIADS, Medical Arts Building
Winnipeg, Manitoba, R3C 3J5
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- HuMax-CD4, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuMax-CD4Drug
Also called Zanolimumab
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.
PlaceboDrug
Placebo was administered as a subcutaneous infusion twice (BID) with 2 weeks interval followed by administration every 4 weeks up to Week 22.
Humax-CD4Drug
Also called Zanolimumab
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| HuMax-CD4 80 milligrams (mg) | Experimental | Not described Receives: Drug: HuMax-CD4 |
| HuMax-CD4 160 mg | Experimental | Not described Receives: Drug: Humax-CD4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with American College of Rheumatology (ACR) 20 Response
Measured: At Week 14 and Week 18
Change from Baseline in Disease Activity Score (DAS)
Measured: Baseline up to Week 26
Change from Baseline in SFP-36 questionnaire at Week 10 and 26
Measured: Baseline, Week 10 and Week 26
Change from Baseline in C-Reactive Protein (CRP)
Measured: Baseline up to Week 26
Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
Measured: Baseline up to Week 26
Number of Participants with Adverse Events (AEs)
Measured: Day 1 up to end of study (Week 26)
Secondary outcomes (2)
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Measured: Up to 26 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2002 (estimated)
- Study start4 Mar 2002
- Primary completion31 Mar 2003
- Study completion31 Mar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042406
- Sponsor's protocol ID
- Hx-CD4-004
- Status last verified
- Apr 2023
- First submitted
- 29 Jul 2002
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00042406
- Acronym / sponsor ID
- Hx-CD4-004
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 83 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2002 (actual)
- Primary completion
- 31 Mar 2003 (actual)
- Study completion
- 31 Mar 2003 (actual)
- First posted
- 1 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| HuMax-CD4 80 milligrams (mg) | Experimental | Drug: HuMax-CD4 |
| HuMax-CD4 160 mg | Experimental | Drug: Humax-CD4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HuMax-CD4Also: ZanolimumabHuMax-CD4 80 mg was administered as a subcutaneous infusion BID with 2 weeks interval followed by administration every 4 weeks up to Week 22. | Drug | HuMax-CD4 80 milligrams (mg) |
| PlaceboPlacebo was administered as a subcutaneous infusion twice (BID) with 2 weeks interval followed by administration every 4 weeks up to Week 22. | Drug | Placebo |
| Humax-CD4Also: ZanolimumabHuMax-CD4 160 mg was administered as a subcutaneous infusion BID with 2 weeks interval followed by administration every 4 weeks up to Week 22. | Drug | HuMax-CD4 160 mg |
Primary outcome
Number of Participants with American College of Rheumatology (ACR) 20 Response
Time frame: At Week 14 and Week 18
Change from Baseline in Disease Activity Score (DAS)
Time frame: 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
Change from Baseline in C-Reactive Protein (CRP)
Time frame: Baseline up to Week 26
Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline up to Week 26
Number of Participants with Adverse Events (AEs)
Time frame: Day 1 up to end of study (Week 26)
2 secondary outcomes
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Time frame: Up to 26 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Up to 26 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
54 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HuMax-CD4 in people with Rheumatoid Arthritis, run by Genmab at 54 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with American College of Rheumatology (ACR) 20 Response (time frame: At Week 14 and Week 18). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.