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

Withdrawn

• Conditions: Ankylosing Spondylitis; Rheumatoid Arthritis; Psoriatic Arthritis
• Interventions: Drug: No intervention

• Registration Number: NCT01692457
• Lead Sponsor: Janssen Pharmaceutica

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.

Study Timeline

• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-25
• Study Start: 2013-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Golimumab	No intervention	Patients will be taking golimumab as per the dosing regimen given on product insert approved in Philippines.

Primary Outcome Measures

Name	Time	Method
Number of patients with incidence of adverse events	From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years
Number of patients with incidence of discontinuation of study medication due to adverse events	From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years

Secondary Outcome Measures

Name	Time	Method
Number of patients who would show improvement using the Health Assessment Questionnaire (HAQ) Score	Baseline, Weeks 4, 8, 12, 16, 20, and 24	HAQ will include 2 scales: (a) scale for evaluating disability (score range, 0 \[without any difficulty\] to 3 \[unable to do\]) and (b) Visual Analogue Scale for evaluating discomfort and pain (score range, 0 \[no pain\] to 100 \[severe pain\]).