A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Centocor, Inc.
Study ID
NCT00265096
Phase
PHASE3
Status
Completed

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • golimumab — BIOLOGICAL
    50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
  • Placebo; golimumab — BIOLOGICAL
    SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg
  • golimumab — BIOLOGICAL
    100 mg sc injections every 4 wks from wk 0 up to 5 yrs

Study Details

The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray related to joint damage, psoriasis skin lesions, physical function, and quality of life.

Key Dates

Start date
Dec 31, 2005
Status verified
Jul 2013
Primary completion
May 31, 2007
Completion
Jan 31, 2012

Study Design

Enrollment
407 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 002
    golimumab 50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
  • Experimental: 001
    Placebo; golimumab SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg
  • Experimental: 003
    golimumab 100 mg sc injections every 4 wks from wk 0 up to 5 yrs

Primary Outcome Measure

American College of Rheumatology (ACR) 20 Response at Week 14 [ Time Frame: Baseline (Week 0), Week 4, Week 8 and Week 14 ]

Locations (18)

FacilityCityStateZIPSite coordinators
-HuntsvilleAlabama--
-La JollaCalifornia--
-UplandCalifornia--
-AventuraFlorida--
-Coeur d'AleneIdaho--
-Kansas CityKansas--
-WheatonMaryland--
-WorcesterMassachusetts--
-OmahaNebraska--
-CincinnatiOhio--
-MayfieldOhio--
-Lake OswegoOregon--
-PortlandOregon--
-DuncansvillePennsylvania--
-West ReadingPennsylvania--
-HoustonTexas--
-EdmondsWashington--
-SeattleWashington--

Related Studies