Trial record 3 of 3272 for:
"Arthritis"
A Study to Assess the Safety and Effectiveness of Golimumab in Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
This study is not yet open for participant recruitment.
Verified April 2013 by Janssen Pharmaceutica
Sponsor:
Janssen Pharmaceutica
Information provided by (Responsible Party):
Janssen Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01692457
First received: September 21, 2012
Last updated: April 12, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis |
Drug: No intervention |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Janssen Pharmaceutica:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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]).
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 Name: SIMPONI
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692457
Contacts
| Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email | JNJ.CT@sylogent.com |
Sponsors and Collaborators
Janssen Pharmaceutica
Investigators
| Study Director: | Janssen Pharmaceutica Clinical Trial | Janssen Pharmaceutica |
More Information
No publications provided
| Responsible Party: | Janssen Pharmaceutica |
| ClinicalTrials.gov Identifier: | NCT01692457 History of Changes |
| Other Study ID Numbers: | CR100823, CNTO148AKS4003, SIM-PHL-MA1, GLR-C-12-PH-001-V01 |
| Study First Received: | September 21, 2012 |
| Last Updated: | April 12, 2013 |
| Health Authority: | Philippine: Food and Drug Administration |
Keywords provided by Janssen Pharmaceutica:
|
Rheumatoid Arthritis Psoriatic Arthritis Arthritis Ankylosing Spondylitis Spondylitis Joint pain |
CNTO148 Golimumab Simponi Filipino Post-Marketing Surveillance |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spinal Diseases Bone Diseases |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Ankylosis |
ClinicalTrials.gov processed this record on May 23, 2013