NCT00051623

Brief Summary

The purpose of this study is to determine if Infliximab is safe and effective in the treatment of psoriatic arthritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2003

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2003

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

May 17, 2011

Status Verified

March 1, 2010

First QC Date

January 14, 2003

Last Update Submit

May 16, 2011

Conditions

Arthritis, Psoriatic

Keywords

Psoriatic arthritisInfliximabRemicade

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with American College of Rheumatology (ACR) 20 response at week 14 Change from baseline in total radiographic scores of hands and feet at week 24

Secondary Outcomes (1)

  • Number of patients who achieved an ACR 20 response at wk 24; PsARC at wk 14; proportion of patients with >= to 75% Improvement From Baseline in PASI at Week 14; change from baseline SF 36 physical component summary scores at wk 14

Interventions

InfliximabDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed psoriatic arthritis for \>= 6 months
  • active arthritis with \>= 5 tender and 5 swollen joints
  • active psoriasis

You may not qualify if:

  • Have other inflammatory diseases, including but not limited to, rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
  • Received any systemic immunosuppressives within 4 weeks prior to enrollment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Bortul M, Calligaris L, Moro E, Bazzocchi M, Strami G. [Preoperative transhepatic biliary drainage in the jaundiced patient: our experience]. Ann Ital Chir. 1991 May-Jun;62(3):265-71; discussion 272. Italian.

    PMID: 1755609BACKGROUND

  • Kavanaugh A, Antoni C, Mease P, Gladman D, Yan S, Bala M, Zhou B, Dooley LT, Beutler A, Guzzo C, Krueger GG. Effect of infliximab therapy on employment, time lost from work, and productivity in patients with psoriatic arthritis. J Rheumatol. 2006 Nov;33(11):2254-9. Epub 2006 Sep 1.

    PMID: 16960923RESULT

  • Kavanaugh A, Krueger GG, Beutler A, Guzzo C, Zhou B, Dooley LT, Mease PJ, Gladman DD, de Vlam K, Geusens PP, Birbara C, Halter DG, Antoni C; IMPACT 2 Study Group. Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial. Ann Rheum Dis. 2007 Apr;66(4):498-505. doi: 10.1136/ard.2006.058339. Epub 2006 Nov 17.

    PMID: 17114188RESULT

  • van der Heijde D, Kavanaugh A, Gladman DD, Antoni C, Krueger GG, Guzzo C, Zhou B, Dooley LT, de Vlam K, Geusens P, Birbara C, Halter D, Beutler A. Infliximab inhibits progression of radiographic damage in patients with active psoriatic arthritis through one year of treatment: Results from the induction and maintenance psoriatic arthritis clinical trial 2. Arthritis Rheum. 2007 Aug;56(8):2698-707. doi: 10.1002/art.22805.

    PMID: 17665424RESULT

  • Englbrecht M, Wang Y, Ronneberger M, Manger B, Vastesaeger N, Veale DJ, Schett G. Measuring joint involvement in polyarticular psoriatic arthritis: an introduction of alternatives. Arthritis Care Res (Hoboken). 2010 Jul;62(7):977-83. doi: 10.1002/acr.20161.

    PMID: 20191568DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Infliximab

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 14, 2003

First Posted

January 15, 2003

Study Start

May 1, 2003

Study Completion

June 1, 2004

Last Updated

May 17, 2011

Record last verified: 2010-03