Clinical trial NCT01692457: A Study to Assess the Safety and Effectiveness of Golimumab in Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Official title: A Post-Marketing Surveillance Study on the Safety and Effectiveness of Golimumab (Simponi) Among Adult Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Keywords: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Arthritis
Spondylitis
Joint pain
CNTO148
Golimumab
Simponi
Filipino
Post-Marketing
Surveillance
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Filipino patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis; and who are on the approved product label of golimumab.

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.

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)

Primary outcomes:
measure: Number of patients with incidence of adverse events
timeFrame: 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
measure: Number of patients with incidence of discontinuation of study medication due to adverse events
timeFrame: 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 outcomes:
measure: Number of patients who would show improvement using the Health Assessment Questionnaire (HAQ) Score
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical Trial
role: STUDY_DIRECTOR
References: