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

NCT ID: NCT01692457

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-07-31

Brief 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.

Detailed Description

This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes) to evaluate the safety and effectiveness of golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among Filipino patients.

The study will enroll approximately 50 patients who would use golimumab with a dosing regimen stipulated in the product insert. As this is an observational study, assessment of patients will be based on the accepted clinical practice in the Philippines. Patients will be monitored from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety evaluations for adverse events, clinical laboratory tests, physical examination, concomitant medications, and co-morbid conditions will be monitored throughout the study. The total study will be conducted for 3 years and duration of treatment will be for 24 weeks.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Golimumab

Patients will be taking golimumab as per the dosing regimen given on product insert approved in Philippines.

No intervention

Intervention Type: DRUG

This is an observational study. Golimumab will be administered as per the recommended doses. Golimumab 50 mg will be given as a subcutaneous injection once a month, on the same date each month. For rheumatoid arthritis: Golimumab 2 mg/kg will be given as a 30 minute intravenous infusion at Weeks 0 and 4, then every 8 weeks thereafter.

Interventions

No intervention

This is an observational study. Golimumab will be administered as per the recommended doses. Golimumab 50 mg will be given as a subcutaneous injection once a month, on the same date each month. For rheumatoid arthritis: Golimumab 2 mg/kg will be given as a 30 minute intravenous infusion at Weeks 0 and 4, then every 8 weeks thereafter.

Intervention Type: DRUG

Other Intervention Names

SIMPONI

Eligibility 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)

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

Sponsors

Janssen Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica

Other Identifiers

CNTO148AKS4003

Identifier Type: OTHER

Identifier Source: secondary_id

SIM-PHL-MA1

Identifier Type: OTHER

Identifier Source: secondary_id

GLR-C-12-PH-001-V01

Identifier Type: OTHER

Identifier Source: secondary_id

CR100823

Identifier Type: -

Identifier Source: org_study_id