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Golimumab in Rheumatoid Arthritis Patients With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)

Information source: Centocor, Inc.
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis; Arthritis, Rheumatoid; Autoimmune Diseases

Intervention: golimumab or placebo (Drug); golimumab (Drug); golimumab or placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Centocor, Inc.

Official(s) and/or principal investigator(s):
Centocor, Inc. Clinical Trial, Study Director, Affiliation: Centocor, Inc.

Overall 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:, Email: info1@veritasmedicine.com

Summary

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.

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To evaluate the efficacy of golimumab + MTX in reducing signs and symptoms of RA (as assessed by American College of Rheumatology [ACR] 20 in patients with inadequate disease control despite treatment with etanercept + MTX or adalimumab + MTX

Secondary outcome:

The efficacy of golimumab 2 mg/kg IV therapy + MTX defined by the relative proportions of randomized patients in the golimumab IV group (with a loading dose) and the golimumab SC groups who achieve an ACR 20 response

Evaluation of safety, additional measures of response, health related outcomes, patient preference,blood tests measuring inflammation, ribonucleic acid (RNA) analysis, trough serum golimumab concentrations, and the development of antibodies to golimumab.

Pharmacogenomics (the study of how people's genetic make-up affects their response to medicines) will also be studied in consenting patients.

The onset of response to golimumab 50 mg SC every 4 weeks + MTX as defined by the proportion of patients who achieve an ACR 20 response

The persistence of response to golimumab 50 mg SC every 4 weeks + MTX as defined by the proportion of patients who achieve a DAS28 "good" response

Detailed description: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have inadequate RA disease control prior to the first administration of study agent

despite treatment with enbrel + methotrexate or humira + methotrexate

- Must have received a stable dose of MTX >=7. 5 mg/week to <=25 mg/week for at least 4

consecutive weeks prior to the first screening visit and must plan to maintain that dose throughout the study

- Patients must have received etanercept or adalimumab in combination with MTX for a

minimum of 3 months prior to the first visit

- Negative tuberculosis test

- Are capable of providing informed consent, which must be obtained prior to any

study-related procedures

Exclusion Criteria:

- Have a history of latent or active granulomatous infection, including TB,

histoplasmosis, or coccidioidomycosis, or are frequently in contact with individuals who carry active TB infection

- Have inflammatory diseases other than RA, including but not limited to psoriatic

arthritis, ankylosing spondylitis, systemic lupus erythematosus, primary Sjogren's or Lyme disease

- Have demonstrated a discernible improvement in disease activity between screening and

prior to the first golimumab injection at Week 0

- Have any known malignancy or have a history of malignancy within the previous 5 years

(with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence)

- Have a history of lymphoproliferative disease, including lymphoma, or signs and

symptoms suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location

Locations and Contacts

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Vienna, Austria; Recruiting

Wien, Austria; Recruiting

Wien N/A, Austria; Recruiting

Brussel, Belgium; Completed

Genk, Belgium; Recruiting

Gent, Belgium; Recruiting

Liège, Belgium; Recruiting

Merksem, Belgium; Recruiting

Quebec, Canada; Recruiting

Göttingen, Germany; Recruiting

Hamburg, Germany; Completed

Hannover, Germany; Recruiting

Herne, Germany; Recruiting

Kiel, Germany; Recruiting

München, Germany; Recruiting

Ratingen, Germany; Recruiting

Athens, Greece; Recruiting

Heraklion- Crete, Greece; Recruiting

Larisa, Greece; Recruiting

Thessalonikis, Greece; Recruiting

Stockholm, Sweden; Recruiting

Cannock, United Kingdom; Recruiting

Leeds, United Kingdom; Recruiting

London, United Kingdom; Recruiting

Manchester, United Kingdom; Recruiting

Merseyside, United Kingdom; Recruiting

Newcastle Upon Tyne, United Kingdom; Recruiting

Wigan, United Kingdom; Recruiting

Birmingham, Alabama, United States; Recruiting

Huntsville, Alabama, United States; Recruiting

Tuscaloosa, Alabama, United States; Recruiting

Edmonton, Alberta, Canada; Recruiting

Mesa, Arizona, United States; Recruiting

Peoria, Arizona, United States; Recruiting

Hot Springs, Arkansas, United States; Recruiting

Little Rock, Arkansas, United States; Recruiting

Kelowna, British Columbia, Canada; Recruiting

Penticton, British Columbia, Canada; Not yet recruiting

Vancouver, British Columbia, Canada; Recruiting

Covina, California, United States; Recruiting

Hemet, California, United States; Recruiting

Loma Linda, California, United States; Recruiting

Long Beach, California, United States; Recruiting

Murrieta, California, United States; Recruiting

Santa Maria, California, United States; Recruiting

Santa Monica, California, United States; Recruiting

Torrance, California, United States; Recruiting

Van Nuys, California, United States; Recruiting

Victorville, California, United States; Recruiting

Whittier, California, United States; Recruiting

Bridgeport, Connecticut, United States; Recruiting

Hamden, Connecticut, United States; Recruiting

Trumbull, Connecticut, United States; Recruiting

Aventura, Florida, United States; Recruiting

Fort Lauderdale, Florida, United States; 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

Port Orange, Florida, United States; Recruiting

Sarasota, Florida, United States; Recruiting

Tampa, Florida, United States; Recruiting

Duluth, Georgia, United States; Recruiting

Coeur D'Alene, Idaho, United States; Recruiting

Idaho Falls, Idaho, United States; Recruiting

Rockford, Illinois, United States; Recruiting

South Bend, Indiana, United States; Recruiting

Bettendorf, Iowa, United States; Recruiting

Kansas City, Kansas, United States; Recruiting

Bowling Green, Kentucky, United States; Recruiting

Baton Rouge, Louisiana, United States; Recruiting

Monroe, Louisiana, United States; Recruiting

New Orleans, Louisiana, United States; Recruiting

Winnipeg, Manitoba, Canada; Recruiting

Towson, Maryland, United States; Recruiting

Wheaton, Maryland, United States; Recruiting

Eagan, Minnesota, United States; Recruiting

Rochester, Minnesota, United States; Recruiting

Flowood, Mississippi, United States; Recruiting

Tupelo, Mississippi, United States; Recruiting

Clayton, Missouri, United States; Recruiting

Florissant, Missouri, United States; Recruiting

Lincoln, Nebraska, United States; Recruiting

Freehold, New Jersey, United States; Recruiting

Brooklyn, New York, United States; Recruiting

Mineola, New York, United States; Recruiting

Plainview, New York, United States; Recruiting

Rochester, New York, United States; Recruiting

Smithtown, New York, United States; Recruiting

Charlotte, North Carolina, United States; Recruiting

Greenville, North Carolina, United States; Recruiting

Hickory, North Carolina, United States; Recruiting

Wilmington, North Carolina, United States; Recruiting

Akron, Ohio, United States; Recruiting

Columbus, Ohio, United States; Recruiting

Mayfield, Ohio, United States; Recruiting

Edmond, Oklahoma, United States; Recruiting

Oklahoma City, Oklahoma, United States; Recruiting

Hamilton, Ontario, Canada; Recruiting

Lake Oswego, Oregon, United States; Recruiting

Bethlehem, Pennsylvania, United States; Recruiting

Duncansville, Pennsylvania, United States; Recruiting

West Reading, Pennsylvania, United States; Recruiting

Wexford, Pennsylvania, United States; Recruiting

Montreal, Quebec, Canada; Completed

Charleston, South Carolina, United States; Recruiting

Columbia, South Carolina, United States; Recruiting

Myrtle Beach, South Carolina, United States; Recruiting

Myrtle Beach, South Carolina, United States; Completed

Hixson, Tennessee, United States; Recruiting

Jackson, Tennessee, United States; Recruiting

Kingsport, Tennessee, United States; Recruiting

Knoxville, Tennessee, United States; Recruiting

Nashville, Tennessee, United States; Recruiting

Austin, Texas, United States; Recruiting

Carrollton, Texas, United States; Recruiting

Dallas, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Arlington, Virginia, United States; Recruiting

Chesapeake, Virginia, United States; Recruiting

Reston, Virginia, United States; Recruiting

Seattle, Washington, United States; Recruiting

Spokane, Washington, United States; Recruiting

Beckley, West Virginia, United States; Recruiting

Clarksburg, West Virginia, United States; Recruiting

Glendale, Wisconsin, United States; Recruiting

Additional Information

To learn how to participate in this trial please click here.

Starting date: December 2009
Last updated: July 14, 2011

Page last updated: December 08, 2011

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