golimumab in rheumatoid arthritis participants with an inadequate response to etanercept (enbrel) or adalimumab (humira)

Conditions: Arthritis; Arthritis, Rheumatoid; Autoimmune Diseases

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.

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.

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

Keywords: humira, remicade rheumatoid arthritis enbrel failure humira failure arthritis enbrel