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

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: Humax-CD4

• Registration Number: NCT00042406
• Lead Sponsor: Genmab

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.

Study Timeline

• Study Start: 2002-03-04
• Study First Submitted: 2002-07-29
• Study First Submitted QC: 2002-07-31
• Study First Posted: 2002-08-01
• Primary Completion: 2003-03-31
• Study Completion: 2003-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
HuMax-CD4 80 milligrams (mg)	Humax-CD4	-
HuMax-CD4 160 mg	Humax-CD4	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Erythrocyte Sedimentation Rate (ESR)	Baseline up to Week 26
Change from Baseline in Disease Activity Score (DAS)	Baseline up to Week 26
Change from Baseline in SFP-36 questionnaire at Week 10 and 26	Baseline, Week 10 and Week 26
Number of Participants with Adverse Events (AEs)	Day 1 up to end of study (Week 26)
Number of Participants with American College of Rheumatology (ACR) 20 Response	At Week 14 and Week 18
Change from Baseline in C-Reactive Protein (CRP)	Baseline up to Week 26

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Significant Laboratory Abnormalities	Up to 26 weeks
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres	Up to 26 weeks

Trial Locations

Locations (52)

Rheumatology Associates; 🇺🇸 Montgomery, Alabama, United States

Pro Health Partners, Inc.; 🇺🇸 Long Beach, California, United States

Rheumatology & Internal Medicine, Boling Clinical Trials; 🇺🇸 Rancho Cucamonga, California, United States

Advances in Medicine; 🇺🇸 Rancho Mirage, California, United States

Radiant Research, Inc.; 🇺🇸 Stuart, Florida, United States

West Coast Clinical Research; 🇺🇸 Van Nuys, California, United States

Arthritis Center of CT; 🇺🇸 Waterbury, Connecticut, United States

Arthritis Associates of South Florida; 🇺🇸 Delray Beach, Florida, United States

Ocala Rheumatology Research Center; 🇺🇸 Ocala, Florida, United States

nTouch Research; 🇺🇸 Decatur, Georgia, United States

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