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| Sponsor: | Centocor, Inc. |
|---|---|
| Collaborator: |
Schering-Plough |
| Information provided by: | Centocor, Inc. |
| ClinicalTrials.gov Identifier: | NCT01004432 |
Purpose
The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) patients who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 mg subcutaneous injection (a needle inserted under your skin in the back of your upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also designed to evaluate the benefit and safety of switching patients from treatment with golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 mg/kg intravenous every 8 weeks + methotrexate, for those who do not achieve a marked improvement of their RA at Week 16.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis Arthritis, Rheumatoid Autoimmune Diseases |
Drug: golimumab Drug: golimumab or placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Golimumab Phase 3b, Multicenter, Switch Assessment of Sequential Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment With Etanercept (ENBREL) or Adalimumab (HUMIRA) |
| Estimated Enrollment: | 400 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
001: Experimental
golimumab Golimumab 50 mg SC injections every 4 weeks through Week 12 (Weeks 0 4 8 and 12) + MTX then Golimumab 50 mg SC every 4 weeks (Weeks 16 20 24 28 32 36 40 44 and 48) + MTX
|
Drug: golimumab
Golimumab 50 mg SC injections every 4 weeks through Week 12 (Weeks 0, 4, 8, and 12) + MTX
|
|
002: Experimental
golimumab or placebo Golimumab 50 mg SC injections every 4 weeks through Week 12 then golimumab 50 mg SC every 4 weeks + MTX. Active golimumab SC injections at Weeks 16 20 24 28 32 36 40 44 and 48. Patients will also receive placebo IV infusions at Weeks 16 20 28 36 and 44
|
Drug: golimumab or placebo
then Golimumab 50 mg SC every 4 weeks (Weeks 16, 20, 24, 28, 32, 36, 40, 44, and 48) + MTX
|
|
003: Experimental
golimumab or placebo Golimumab 50 mg SC injections every 4 weeks through Week 12 then golimumab 2 mg/kg IV every 8 weeks + MTX. Active golimumab IV infusions at Weeks 16 20 28 36 and 44. Patients will also receive placebo SC injections at Weeks 16 20 24 28 32 36 40 44 and 48.
|
Drug: golimumab or placebo
Golimumab 50 mg SC injections every 4 weeks through Week 12, then golimumab 50 mg SC every 4 weeks + MTX. Active golimumab SC injections at Weeks 16, 20, 24, 28, 32, 36, 40, 44, and 48. Patients will also receive placebo IV infusions at Weeks 16, 20, 28, 36, and 44
|
The main purpose of this study is to assess the effects (good and bad) of golimumab for rheumatoid arthritis (RA) in patients previously treated with another tumor necrosis factor (TNF) inhibitor. Golimumab is a type of TNF inhibitor. TNF is a naturally occurring substance in the body and this substance may cause long-term inflammation. Golimumab may help fight your disease by blocking the activity of TNF in your body. This study will assess the safety of golimumab and determine if there is a reduction of the pain and swelling in the joints of patients with rheumatoid arthritis treated with golimumab. The effect of golimumab on physical function, and the quality of life in patients with rheumatoid arthritis will also be assessed. Golimumab will be given by a subcutaneous injection (SC) every 4 weeks at doses of 50 mg and possibly by intravenous injection (IV) every 8 weeks at 2 mg/kg. Golimumab is given by a SC injection with a needle inserted under your skin in the back of your upper arm, your upper thigh, stomach area or by IV in your arm. If you are eligible to take part in this study, you will initiate treatment with open-label golimumab SC injections every 4 weeks. During the first 12 weeks you and your doctor will know what medication you are receiving, this is called open-label. Starting at Week 16, depending on how your RA has improved, you will be put into one of three groups where each group gets a different treatment. If your study doctor sees an improvement of in your disease you can continue to receive an injection of golimumab 50 mg SC every 4 weeks through Week 48. If your disease has not improved you will be randomly placed into one of two study groups. You will have approximately a one in three chance of being put in the group receiving golimumab 50mg SC every four weeks along with placebo drug IV every eight weeks and a two in three chance of being put in the group receiving 2mg/kg IV every eight weeks along with placebo SC every four weeks. Starting with Week 16 if you are placed in Group 1, the study will remain open labeled. If you are randomized to Groups 2a or 2b, the study is "blinded." This means that neither you nor your study doctor will know in which group you are placed. However, if needed for safety or health reasons, your study doctor can find out your treatment at any time. Placebo is an inactive treatment that looks the same as the study drug golimumab, but does not contain any active medication. Your disease will be measured by your physician using standards called American College of Rheumatology (ACR) 20 and Disease Activity Score (DAS) 28. For example, if a study reported that 55% of patients achieved ACR20, that means 55% of patients in the study achieved a 20% improvement in tender or swollen joint counts as well as 20% improvement in three of the other five criteria. DAS28 is based on counts of the number of painful joints and the number of swollen joints you have out of 28 joints. All patients will receive golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate for 16 weeks. Patients whose disease shows pronounced improvement will continue to receive this therapy every 4 weeks for 36 more weeks. Patients who do not achieve a DAS-28 "good" response, as defined by EULAR criteria, will receive either golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate for 36 more weeks OR golimumab 2 mg/kg IV every 8 weeks + methotrexate for 34 more weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Hide Study Locations| United States, Alabama | |
| Recruiting | |
| Birmingham, Alabama, United States | |
| Recruiting | |
| Huntsville, Alabama, United States | |
| Recruiting | |
| Tuscaloosa, Alabama, United States | |
| United States, Arizona | |
| Recruiting | |
| Mesa, Arizona, United States | |
| Recruiting | |
| Peoria, Arizona, United States | |
| United States, Arkansas | |
| Recruiting | |
| Hot Springs, Arkansas, United States | |
| Recruiting | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| Recruiting | |
| Covina, California, United States | |
| Recruiting | |
| Hemet, California, United States | |
| Recruiting | |
| Long Beach, California, United States | |
| Recruiting | |
| Santa Maria, California, United States | |
| Recruiting | |
| Santa Monica, California, United States | |
| Recruiting | |
| Victorville, California, United States | |
| Recruiting | |
| Whittier, California, United States | |
| United States, Connecticut | |
| Recruiting | |
| Bridgeport, Connecticut, United States | |
| United States, Florida | |
| Recruiting | |
| Aventura, Florida, United States | |
| Recruiting | |
| Fort Lauderdale, Florida, United States | |
| Not yet recruiting | |
| Naples, Florida, United States | |
| Recruiting | |
| Orange Park, Florida, United States | |
| Recruiting | |
| Orlando, Florida, United States | |
| Recruiting | |
| Palm Harbor, Florida, United States | |
| Recruiting | |
| Plantation, Florida, United States | |
| Recruiting | |
| Sarasota, Florida, United States | |
| Recruiting | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| Recruiting | |
| Duluth, Georgia, United States | |
| United States, Idaho | |
| Recruiting | |
| Coeur D'Alene, Idaho, United States | |
| Recruiting | |
| Idaho Falls, Idaho, United States | |
| United States, Illinois | |
| Recruiting | |
| Rockford, Illinois, United States | |
| United States, Iowa | |
| Recruiting | |
| Bettendorf, Iowa, United States | |
| United States, Louisiana | |
| Recruiting | |
| Monroe, Louisiana, United States | |
| United States, Maryland | |
| Recruiting | |
| Wheaton, Maryland, United States | |
| United States, Mississippi | |
| Recruiting | |
| Flowood, Mississippi, United States | |
| United States, Missouri | |
| Recruiting | |
| Clayton, Missouri, United States | |
| United States, Nebraska | |
| Recruiting | |
| Lincoln, Nebraska, United States | |
| United States, New Jersey | |
| Recruiting | |
| Freehold, New Jersey, United States | |
| United States, New York | |
| Recruiting | |
| Brooklyn, New York, United States | |
| Recruiting | |
| Plainview, New York, United States | |
| Recruiting | |
| Rochester, New York, United States | |
| United States, North Carolina | |
| Recruiting | |
| Charlotte, North Carolina, United States | |
| Recruiting | |
| Greenville, North Carolina, United States | |
| Recruiting | |
| Wilmington, North Carolina, United States | |
| United States, Ohio | |
| Recruiting | |
| Columbus, Ohio, United States | |
| United States, Oklahoma | |
| Recruiting | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Recruiting | |
| Bethlehem, Pennsylvania, United States | |
| Recruiting | |
| Duncansville, Pennsylvania, United States | |
| Recruiting | |
| Philadelphia, Pennsylvania, United States | |
| Recruiting | |
| West Reading, Pennsylvania, United States | |
| Recruiting | |
| Wexford, Pennsylvania, United States | |
| United States, South Carolina | |
| Recruiting | |
| Charleston, South Carolina, United States | |
| Recruiting | |
| Columbia, South Carolina, United States | |
| United States, Tennessee | |
| Recruiting | |
| Hixson, Tennessee, United States | |
| Recruiting | |
| Jackson, Tennessee, United States | |
| Recruiting | |
| Knoxville, Tennessee, United States | |
| United States, Texas | |
| Recruiting | |
| Austin, Texas, United States | |
| Not yet recruiting | |
| Carrollton, Texas, United States | |
| Recruiting | |
| Dallas, Texas, United States | |
| Not yet recruiting | |
| Dallas, Texas, United States | |
| Recruiting | |
| Houston, Texas, United States | |
| Not yet recruiting | |
| Houston, Texas, United States | |
| Recruiting | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Recruiting | |
| Arlington, Virginia, United States | |
| Recruiting | |
| Chesapeake, Virginia, United States | |
| United States, Washington | |
| Recruiting | |
| Seattle, Washington, United States | |
| Recruiting | |
| Spokane, Washington, United States | |
| United States, West Virginia | |
| Recruiting | |
| Beckley, West Virginia, United States | |
| Recruiting | |
| Clarksburg, West Virginia, United States | |
| United States, Wisconsin | |
| Recruiting | |
| Glendale, Wisconsin, United States | |
| Belgium | |
| Recruiting | |
| Gent, Belgium | |
| Recruiting | |
| Liège, Belgium | |
| Recruiting | |
| Merksem, Belgium | |
| Canada, British Columbia | |
| Not yet recruiting | |
| Kelowna, British Columbia, Canada | |
| Recruiting | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Recruiting | |
| Hamilton, Ontario, Canada | |
| Canada, Quebec | |
| Recruiting | |
| Montreal, Quebec, Canada | |
| Canada | |
| Recruiting | |
| Quebec, Canada | |
| Germany | |
| Recruiting | |
| Hamburg, Germany | |
| Recruiting | |
| München, Germany | |
| Recruiting | |
| Ratingen, Germany | |
| Sweden | |
| Recruiting | |
| Stockholm, Sweden | |
| United Kingdom | |
| Recruiting | |
| London, United Kingdom | |
| Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
More Information
| Responsible Party: | Centocor ( SENIOR DIRECTOR MA STRATETIC TRIAL TEAM ) |
| ClinicalTrials.gov Identifier: | NCT01004432 History of Changes |
| Other Study ID Numbers: | CR016663, CNTO148ART3002, 2009-010582-23, GO SAVE |
| Study First Received: | October 29, 2009 |
| Last Updated: | August 19, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
rheumatoid arthritis enbrel failure humira failure subcutaneous injection |
arthritis IV enbrel humira, remicade |
|
Arthritis Arthritis, Rheumatoid Autoimmune Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Immune System Diseases TNFR-Fc fusion protein Immunoglobulin G Adalimumab Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors Central Nervous System Agents |