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

NCT ID: NCT01004432

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 433 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-10-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) participants who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also designed to evaluate the benefit and safety of switching participants from treatment with golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a marked improvement of their RA at Week 16.

Detailed Description

The study consists of a main study and a voluntary, open-label (participants and researchers are aware about the treatment participants are receiving), 24-week study extension. The main study includes a Screening Run-in Period (Week -6 to Week 0), an Open-label Treatment Period (Week 0 to Week 16), an Open-label or Double-blind Treatment Period (Week 16 to Week 52). The main study also includes a Follow-up Period from Week 52 through Week 64 for those participants who will not participate in the 24-week study extension. Participants, participating in 24-week extension (at Week 52), will receive open-label golimumab SC injections every 4 weeks from Week 52 up to Week 72 and will be followed-up up to Week 88. All eligible participants will initiate the treatment with open-label golimumab SC injection every 4 weeks up to Week 12. At Week 16, depending upon the treatment response either participants will continue to receive open-label golimumab SC injection every 4 weeks up to Week 48 or participants will be randomly assigned to receive following 2 treatments: 1- golimumab 50mg SC injection every 4 weeks along with placebo intravenous infusion every 8 weeks through Week 48; 2- Placebo SC injection every 4 weeks along with golimumab 2mg/kg intravenous infusion every 8 weeks through Week 48. At Week 52, participants who choose to participate in the 24-week study extension will receive open-label golimumab 50 mg SC injections every 4 weeks through Week 72. Participants' safety will be monitored throughout the study.

Conditions

Arthritis; Arthritis, Rheumatoid; Autoimmune Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX

All enrolled and dosed participants receive golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 0 to Week 12.

Group Type: EXPERIMENTAL

Golimumab 50 mg SC

Intervention Type: DRUG

Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.

Methotrexate (MTX)

Intervention Type: DRUG

Participants will continue taking their current Methotrexate (MTX) treatment regimen.

Double blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX

Participants, who do not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, will be randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.

Group Type: EXPERIMENTAL

Golimumab 50 mg SC

Intervention Type: DRUG

Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.

Methotrexate (MTX)

Intervention Type: DRUG

Participants will continue taking their current Methotrexate (MTX) treatment regimen.

Placebo IV

Intervention Type: DRUG

Placebo matched to golimumab intravenous infusion every 8 weeks.

DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX

Participants, who do not achieve DAS28 good response at Week 16, will be randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.

Group Type: EXPERIMENTAL

Golimumab 2 mg/kg IV

Intervention Type: DRUG

Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks.

Methotrexate (MTX)

Intervention Type: DRUG

Participants will continue taking their current Methotrexate (MTX) treatment regimen.

Placebo SC

Intervention Type: DRUG

Placebo matched to golimumab SC injection every 4 weeks.

OL Group 1: Golimumab 50 mg SC + MTX

Participants, who achieve DAS28 good response at Week 16, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48.

Group Type: EXPERIMENTAL

Golimumab 50 mg SC

Intervention Type: DRUG

Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.

Methotrexate (MTX)

Intervention Type: DRUG

Participants will continue taking their current Methotrexate (MTX) treatment regimen.

OL Study Extension Group: Golimumab 50 mg SC + MTX

Participants who complete the main study (Week 0 to Week 52), do not meet lack of efficacy criteria, and participate in the OL study extension, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.

Group Type: EXPERIMENTAL

Golimumab 50 mg SC

Intervention Type: DRUG

Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.

Methotrexate (MTX)

Intervention Type: DRUG

Participants will continue taking their current Methotrexate (MTX) treatment regimen.

Interventions

Golimumab 50 mg SC

Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.

Intervention Type: DRUG

Golimumab 2 mg/kg IV

Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks.

Intervention Type: DRUG

Methotrexate (MTX)

Participants will continue taking their current Methotrexate (MTX) treatment regimen.

Intervention Type: DRUG

Placebo SC

Placebo matched to golimumab SC injection every 4 weeks.

Intervention Type: DRUG

Placebo IV

Placebo matched to golimumab intravenous infusion every 8 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have inadequate RA disease control prior to the first administration of study agent despite treatment with etanercept (Enbrel) + methotrexate or adalimumab (Humira) + methotrexate (MTX)
• Must have received a stable dose of MTX greater than or equal to (>=) 7.5 milligram (mg) per week to less than or equal to (<=) 25 mg per week for at least 4 consecutive weeks prior to the first screening visit and must plan to maintain that dose throughout the study
• Participants must have received etanercept or adalimumab in combination with MTX for a minimum of 3 months prior to the first visit
• Negative tuberculosis (TB) 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Janssen Biotech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Biotech, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Biotech, Inc.

Locations

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Tuscaloosa, Alabama, United States

Mesa, Arizona, United States

Phoenix, Arizona, United States

Hot Springs, Arkansas, United States

Little Rock, Arkansas, United States

Covina, California, United States

Hemet, California, United States

Loma Linda, California, United States

Long Beach, California, United States

Murrieta, California, United States

Santa Maria, California, United States

Santa Monica, California, United States

Torrance, California, United States

Van Nuys, California, United States

Victorville, California, United States

Whittier, California, United States

Bridgeport, Connecticut, United States

Hamden, Connecticut, United States

Trumbull, Connecticut, United States

Aventura, Florida, United States

Fort Lauderdale, Florida, United States

Jacksonville, Florida, United States

Naples, Florida, United States

Orange Park, Florida, United States

Orlando, Florida, United States

Palm Harbor, Florida, United States

Plantation, Florida, United States

Sarasota, Florida, United States

Tampa, Florida, United States

Duluth, Georgia, United States

Coeur d'Alene, Idaho, United States

Idaho Falls, Idaho, United States

Rockford, Illinois, United States

South Bend, Indiana, United States

Bettendorf, Iowa, United States

Kansas City, Kansas, United States

Bowling Green, Kentucky, United States

Monroe, Louisiana, United States

New Orleans, Louisiana, United States

Wheaton, Maryland, United States

Rochester, Minnesota, United States

Flowood, Mississippi, United States

Tupelo, Mississippi, United States

Clayton, Missouri, United States

Florissant, Missouri, United States

Lincoln, Nebraska, United States

Freehold, New Jersey, United States

Brooklyn, New York, United States

Mineola, New York, United States

Plainview, New York, United States

Rochester, New York, United States

Smithtown, New York, United States

Charlotte, North Carolina, United States

Greenville, North Carolina, United States

Hickory, North Carolina, United States

Wilmington, North Carolina, United States

Akron, Ohio, United States

Columbus, Ohio, United States

Mayfield, Ohio, United States

Middleburg Heights, Ohio, United States

Edmond, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Lake Oswego, Oregon, United States

Bethlehem, Pennsylvania, United States

Duncansville, Pennsylvania, United States

West Reading, Pennsylvania, United States

Wexford, Pennsylvania, United States

Charleston, South Carolina, United States

Columbia, South Carolina, United States

Myrtle Beach, South Carolina, United States

Hixson, Tennessee, United States

Jackson, Tennessee, United States

Kingsport, Tennessee, United States

Knoxville, Tennessee, United States

Nashville, Tennessee, United States

Austin, Texas, United States

Carrollton, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Arlington, Virginia, United States

Chesapeake, Virginia, United States

Seattle, Washington, United States

Spokane, Washington, United States

Beckley, West Virginia, United States

Clarksburg, West Virginia, United States

Glendale, Wisconsin, United States

Vienna, , Austria

Brussels, , Belgium

Genk, , Belgium

Ghent, , Belgium

Liège, , Belgium

Merksem, , Belgium

Edmonton, Alberta, Canada

Kelowna, British Columbia, Canada

Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

Hamilton, Ontario, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

St. Johns, , Canada

Hamburg, , Germany

Herne, , Germany

München, , Germany

Ratingen, , Germany

Heraklion- Crete, , Greece

Thessalonikis, , Greece

Stockholm, , Sweden

Cannock, , United Kingdom

Leeds, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Merseyside, , United Kingdom

Newcastle upon Tyne, , United Kingdom

Wigan, , United Kingdom

Countries

United States; Austria; Belgium; Canada; Germany; Greece; Sweden; United Kingdom

References

Dehoratius RJ, Brent LH, Curtis JR, Ellis LA, Tang KL. Satisfaction with Subcutaneous Golimumab and its Auto-Injector among Rheumatoid Arthritis Patients with Inadequate Response to Adalimumab or Etanercept. Patient. 2018 Jun;11(3):361-369. doi: 10.1007/s40271-018-0297-5.

Reference Type: DERIVED

PMID: 29427176 (View on PubMed)

Huffstutter JE, Kafka S, Brent LH, Matucci-Cerinic M, Tang KL, Chevrier M, Sprabery T, DeHoratius RJ. Clinical response to golimumab in rheumatoid arthritis patients who were receiving etanercept or adalimumab: results of a multicenter active treatment study. Curr Med Res Opin. 2017 Apr;33(4):657-666. doi: 10.1080/03007995.2016.1277195. Epub 2017 Jan 25.

Reference Type: DERIVED

PMID: 28035867 (View on PubMed)

Other Identifiers

CNTO148ART3002

Identifier Type: OTHER

Identifier Source: secondary_id

2009-010582-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO SAVE

Identifier Type: OTHER

Identifier Source: secondary_id

CR016663

Identifier Type: -

Identifier Source: org_study_id