Trial With HuMax-CD4 in Patients With Rheumatoid Arthritis Failing Treatment With Methotrexate and a TNF-alpha Blocker
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether HuMax-CD4 is effective in the treatment of active rheumatoid arthritis in patients who have failed treatment with Methotrexate and at least one TNF-alpha blocking agent.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Detailed Description
This is a multi-center, double-blind, placebo-controlled, parallel-group, randomized trial of HuMax-CD4 in the treatment of patients with active rheumatoid arthritis (RA) who have failed treatment with Methotrexate (MTX) and at least one TNF-alpha blocking agent. Patients 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
|
| Experimental: HuMax-CD4 80 mg 80 mg |
Drug: HuMax-CD4
|
| Experimental: HuMax-CD4 160 mg 160 mg |
Drug: HuMax-CD4
|
Outcome Measures
Primary Outcome Measures
- ACR20 [26 weeks]
Secondary Outcome Measures
- Adverse Events [26 weeks]
Eligibility Criteria
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.
-
Unable to tolerate Methotrexate, or lack of efficacy after a minimum of 6 months treatment.
-
Failure to tolerate treatment with either Enbrel or Remicade, or lack of efficacy after at least 3 months treatment with one of these agents.
Exclusion Criteria:
-
Active autoimmune disease requiring therapy (other than rheumatoid arthritis and secondary Sjögren's disease).
-
The use of certain treatments or drugs for treatment of rheumatoid arthritis within 4 weeks of participation in the trial.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rheumatology Associates | Montgomery | Alabama | United States | 36111-2654 |
| 2 | Pro Health Partners, Inc. | Long Beach | California | United States | 90813-3412 |
| 3 | Rheumatology & Internal Medicine, Boling Clinical Trials | Rancho Cucamonga | California | United States | 91730 |
| 4 | Advances in Medicine | Rancho Mirage | California | United States | 92270 |
| 5 | Radiant Research, Inc. | San Diego | California | United States | 92108 |
| 6 | West Coast Clinical Research | Van Nuys | California | United States | 91405 |
| 7 | Arthritis Center of CT | Waterbury | Connecticut | United States | 06708 |
| 8 | Arthritis Associates of South Florida | Delray Beach | Florida | United States | 33484 |
| 9 | Ocala Rheumatology Research Center | Ocala | Florida | United States | 34474 |
| 10 | nTouch Research | St. Petersburg | Florida | United States | 33707 |
| 11 | Radiant Research, Inc. | Stuart | Florida | United States | 34996 |
| 12 | Tampa Medical Group Research | Tampa | Florida | United States | 33614 |
| 13 | nTouch Research | Decatur | Georgia | United States | 30033 |
| 14 | North Western Center for Clinical Research | Chicago | Illinois | United States | 60611 |
| 15 | Rheumatology Associates, P.C. | Chicago | Illinois | United States | 60612 |
| 16 | Advocate Medical Group | Park Ridge | Illinois | United States | 60068 |
| 17 | The Arthritis Center | Springfield | Illinois | United States | 62704 |
| 18 | Deerbrook Medical Associates | Vernon Hills | Illinois | United States | 60061 |
| 19 | West Pharmaceutical Services | Evansville | Indiana | United States | 47714 |
| 20 | Idaho Arthritis & Osteoporosis Center | Meridian | Indiana | United States | 83642 |
| 21 | Mercy Arthritis Center | Des Moines | Iowa | United States | 50322 |
| 22 | University of Louisville Hospital | Louisville | Kentucky | United States | 40202 |
| 23 | Osteoporosis and Clinical Trials Center | Hagerstown | Maryland | United States | 21740 |
| 24 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 25 | Arthritis Education and Treatment Center | Grand Rapids | Michigan | United States | 49503 |
| 26 | Midwest Arthritis Center | Kalamazoo | Michigan | United States | 49001 |
| 27 | Fiechtner Research | Lansing | Michigan | United States | 48910 |
| 28 | Westroads Medical Group | Omaha | Nebraska | United States | 68114 |
| 29 | Arthritis Center of Reno | Reno | Nevada | United States | 89502 |
| 30 | One Crouse Medical Plaza | Syracuse | New York | United States | 13210 |
| 31 | C.A.R.E. Center | Raleigh | North Carolina | United States | 27609 |
| 32 | DataPharm, Inc. | Canfield | Ohio | United States | 44406 |
| 33 | Disease Study Group / Deaconess Hospital | Cincinnati | Ohio | United States | 45219 |
| 34 | Lynn Health Science | Oklahoma City | Oklahoma | United States | 73112 |
| 35 | Bend Memorial Clinic | Bend | Oregon | United States | 97701 |
| 36 | Rheumatology Clinic | Medford | Oregon | United States | 97504 |
| 37 | Providence Arthritis Center | Portland | Oregon | United States | 97213 |
| 38 | Northwest Rheumatology Associates, PC | Portland | Oregon | United States | 97225 |
| 39 | East Pennsylvania Rheumatology | Bethlehem | Pennsylvania | United States | 18015 |
| 40 | Altoona Arthritis & Osteoporosis Center | Duncansville | Pennsylvania | United States | 16635-0909 |
| 41 | Clinical Research Center of Reading | West Reading | Pennsylvania | United States | 19611 |
| 42 | Presbyterian Hospital of Dallas | Dallas | Texas | United States | 75231 |
| 43 | IHC Clinical Research Foundation | Salt Lake City | Utah | United States | 84102 |
| 44 | Medical College of Virginia, Div. of Rheum. | Richmond | Virginia | United States | 23298-0647 |
| 45 | Lewis Gayle Clinic | Salem | Virginia | United States | 24153 |
| 46 | Evergreen Medical & Dental Center | Kirkland | Washington | United States | 98034 |
| 47 | South Puget Sound Clinical Research Center | Olympia | Washington | United States | 98502 |
| 48 | Minor & James Med., First Hill Medical Building | Seattle | Washington | United States | 98104 |
| 49 | Internal Medicine Association of Yakima, Inc., P.S. | Yakima | Washington | United States | 98902 |
| 50 | Medical Arts Center | Milwaukee | Wisconsin | United States | 53211 |
| 51 | CIADS, Medical Arts Building | Winnipeg | Manitoba | Canada | R3C 3J5 |
| 52 | Ottawa Hospital-General Campus | Ottawa | Ontario | Canada | K1H 8L6 |
| 53 | Sunnybrook/Women's College Research Health Science Center | Toronto | Ontario | Canada | M4N 3M5 |
| 54 | Institute de Rhumtologie de Montreal | Montreal | Quebec | Canada | H2L 1S6 |
Sponsors and Collaborators
- Emergent Product Development Seattle LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Hx-CD4-004