Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy - Full Text View

Purpose

Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying anti-Rheumatic Drug Therapy

Condition	Intervention	Phase
Arthritis Psoriatic	Drug: adalimumab Drug: placebo for adalimumab	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy

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:

ACR20 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: Throughout the Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

ACR50/70 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Modified Psoriatic Arthritis Response Criteria [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Multiple QOL Assessments [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Physicians Global Assessment for Psoriasis [ Time Frame: Week 12 ] [ Designated as safety issue: No ]


Enrollment:	102
Study Start Date:	June 2003
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A	Drug: adalimumab 40 mg adalimumab eow Week 0 - Week 12 Other Names: ABT-D2E7 Humira
Placebo Comparator: B	Drug: placebo for adalimumab placebo eow Week 0 - Week 12 Other Name: placebo

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Moderate to severe PsA
Inadequate response to DMARD therapy
Corticosteroid stable dose <=10 mg QD
DMARDs must have been taken for 3 months and stable dose for 4 weeks
MTX maximum dose = <=30 mg/week
Active chronic plaque PS or documented history of chronic plaque PS

Exclusion Criteria:

No other active skin disease

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.

No Contacts or Locations Provided

More Information


Responsible Party:	Beverly Paperiello / Director, Clinical Research Development, Abbott
ClinicalTrials.gov Identifier:	NCT00646178 History of Changes
Other Study ID Numbers:	M02-570
Study First Received:	March 26, 2008
Last Updated:	March 26, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases	Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Adalimumab Antirheumatic Agents Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 29, 2016