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

NCT01692457 | Withdrawn

• 4 other identifiers: CR100823CNTO148AKS4003SIM-PHL-MA1GLR-C-12-PH-001-V01
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of patients who would show improvement using the Health Assessment Questionnaire (HAQ) Score

  Baseline, Weeks 4, 8, 12, 16, 20, and 24

Study Arms (1)

Golimumab

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

Drug: No intervention

Interventions

No intervention 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.

Also known as: SIMPONI

Golimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Pharmaceutica: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Arthritis; Spondylitis; Arthralgia

Interventions

golimumab

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis; Bone Diseases, Infectious; Infections; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Pharmaceutica Clinical Trial

  Janssen Pharmaceutica

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 25, 2012
• Study Start: July 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 2, 2015

Record last verified: 2015-11