A Study to Assess the Safety and Effectiveness of Golimumab in Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

• Status: Withdrawn
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and effectiveness of golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among Filipino patients.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutica
• Treatments: Antibodies, Monoclonal; Golimumab

Criteria

Inclusion Criteria:

• Have rheumatoid arthritis and exhibit at least four of the following criteria: morning stiffness for at least one hour and present for at least six weeks, swelling of three or more joints for at least six weeks, swelling of wrist, metacarpophalangeal or proximal interphalangeal joints for six or more weeks, symmetrical joint swelling, X-ray changes of hand that include erosions or unequivocal bony decalcification, rheumatoid nodules, serum rheumatoid factor by a method positive in less than 5 percent of normal

• Have ankylosing spondylitis and must have either of the following: Grade 3-4 sacroiliitis with at least one clinical criterion, Grade 3-4 unilateral sacroiliitis, Grade 2 bilateral sacroiliitis with clinical criterion 1 (limitation of motion of the lumbar spine in all 3 planes: anterior flexion, lateral flexion, extension) or criterion 2 (history of pain in the lumbar spine or at the dorso-lumbar junction) and criterion 3 (limited chest expansion to 2.5 cm or less, measured at the fourth intercostals line)

• Have psoriatic arthritis and includes 3 of the following conditions: an inflammatory arthritis (peripheral arthritis and/or sacroiliitis or spondylitis), the presence of psoriasis, the (usual) absence of serological tests for rheumatoid factor

Exclusion Criteria:

• Known hypersensitivity to golimumab or to any of the components of the agent preparation

• Pregnant or breastfeeding females

• Not agreeing to protocol-defined use of effective contraception

• Patients receiving live vaccines while on treatment

• Patients with documented clinically important, active infection (eg, active tuberculosis infection)

• Patients with documented past and current history of malignancy and significant cytopenias (reduction in the number of blood cells)