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

November 30, 2015 updated by: Janssen Pharmaceutica

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Golimumab
Patients will be taking golimumab as per the dosing regimen given on product insert approved in Philippines.
Drug: 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.
Other Names:
  • SIMPONI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with incidence of adverse events
Time Frame: 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
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
Time Frame: 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
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

Outcome Measure
Measure Description
Time Frame
Number of patients who would show improvement using the Health Assessment Questionnaire (HAQ) Score
Time Frame: 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]).
Baseline, Weeks 4, 8, 12, 16, 20, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100823
  • CNTO148AKS4003 (Other Identifier: Janssen Pharmaceutica)
  • SIM-PHL-MA1 (Other Identifier: Janssen Pharmaceutica)
  • GLR-C-12-PH-001-V01 (Other Identifier: Janssen Pharmaceutica)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe