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

PHRR120921-000006

CNTO148AKS4003

Unspecified

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.

Start Date Duration in Months Target Completion Date Actual Completion Date
2013-07-01 36 2016-07-01 0000-00-00

Suspended

The company decided to cancel this study, as per FDA circular FDA 2013-004.

Institution Classification Region LTO #
Janssen Pharmaceuticals, Inc. Private Business NCR
Institution Region
Janssen Pharmaceuticals, Inc. NCR
Name E-Mail Phone Number Postal Address
Erwin G. Benedicto, MD ebenedic@its.jnj.com 623 8248935 Janssen Pharmaceutical Companies of Johnson and Johnson Philippines Inc., Edison Road, Barrio Ibayo, 1700 Paranaque City, Philippines
Name E-Mail Phone Number Postal Address
Erwin G. Benedicto, MD ebenedic@its.jnj.com 623 8248935 Janssen Pharmaceutical Companies of Johnson and Johnson Philippines Inc., Edison Road, Barrio Ibayo, 1700 Paranaque City, Philippines
Name Expertise Affiliation
Not applicable Not applicable TBD
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
TBD Not applicable Not applicable Not applicable
Project Location Institutional Ethics Review Board
TBD TBD

Clinical Trial

Unspecified

Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

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, Y. 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, Y.

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]), N.

Suspended

  • Philippines

CNTO148AKS4003

Unspecified

Unspecified

0000-00-00

Protocol Code Number CNTO148AKS4003
Protocol Version Unspecified
Date of Protocol Version Unspecified

50

Unspecified

TBD - Not yet started

Unspecified

01 Jul 2013

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 dorsolumbar 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)

Observational

Unspecified

Unspecified

None

Method of Allocation

Non-randomized

Masking or Blinding

Open-label

Masking Details

Unspecified

Control

Unspecified

Assignment

Single Arm

Phase

Phase IV

Purpose of the Study

Conducted after the national drug registration authority (i.e. FDA) has approved a drug for distribution or marketing.

Detailed purpose of the study

Unspecified

Plan to Share IPD

Unspecified

IPD Description

Unspecified

Date of posting of result summaries

Unspecified

Date of the first journal publication of results

Unspecified

URL hyperlinks related to results and publications

Unspecified

URL link to protocol files(s) with version and data

Unspecified

Baseline Characteristics

Unspecified

Participant Flow

Unspecified

Adverse Events

Unspecified

Outcome Measures

Unspecified

Brief Summary

Unspecified

Utilization Utilization Info
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