NCT00195689

Brief Summary

The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis

Trial Health

80
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

August 29, 2007

Status Verified

August 1, 2007

First QC Date

September 13, 2005

Last Update Submit

August 28, 2007

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (7)

  • Safety parameters

  • ACR 20/50/70

  • PsARC

  • HAQ

  • SF-36

  • FACTIT Fatigue Scale

  • Disease progression measurements

Secondary Outcomes (2)

  • Patient reported outcomes

  • Clinical response indicators

Interventions

Human anti-TNF monoclonal antibody/adalimumabBIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Subject completed study M02-518 or M02-570

You may not qualify if:

  • Subject prematurely discontinued study M02-518 or M02-570
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Global Medical Information-Abbott Laboratories

Abbott Park, Illinois, 60064, United States

Location

Related Publications (2)

  • Gladman DD, Mease PJ, Choy EH, Ritchlin CT, Perdok RJ, Sasso EH. Risk factors for radiographic progression in psoriatic arthritis: subanalysis of the randomized controlled trial ADEPT. Arthritis Res Ther. 2010;12(3):R113. doi: 10.1186/ar3049. Epub 2010 Jun 10.

    PMID: 20537151DERIVED

  • Mease PJ, Ory P, Sharp JT, Ritchlin CT, Van den Bosch F, Wellborne F, Birbara C, Thomson GT, Perdok RJ, Medich J, Wong RL, Gladman DD. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009 May;68(5):702-9. doi: 10.1136/ard.2008.092767. Epub 2008 Aug 6.

    PMID: 18684743DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Beverly Paperiello

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

August 1, 2003

Last Updated

August 29, 2007

Record last verified: 2007-08

Locations

US(1)