Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis - Full Text View

Purpose

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

Condition	Intervention	Phase
Psoriatic Arthritis	Biological: Human anti-TNF monoclonal antibody/adalimumab	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to Severely Active Psoriatic Arthritis

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Arthritis Psoriatic Arthritis

Drug Information available for: Adalimumab

Genetic and Rare Diseases Information Center resources: Spondylarthropathy

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Safety parameters
ACR 20/50/70
PsARC
HAQ
SF-36
FACTIT Fatigue Scale
Disease progression measurements

Secondary Outcome Measures:

Patient reported outcomes
Clinical response indicators


Estimated Enrollment:	400
Study Start Date:	August 2003

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject completed study M02-518 or M02-570

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195689

Locations


United States, Illinois
Global Medical Information-Abbott Laboratories
Abbott Park, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Beverly Paperiello	Abbott

More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


ClinicalTrials.gov Identifier:	NCT00195689 History of Changes
Other Study ID Numbers:	M02-537
Study First Received:	September 13, 2005
Last Updated:	August 28, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Spinal Diseases Spondylarthritis	Spondylarthropathies Spondylitis Adalimumab Antibodies, Monoclonal Anti-Inflammatory Agents Antirheumatic Agents Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015