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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646178

Enrollment

102

Registered

2008-03-28

Start date

2003-06-30

Completion date

Unknown

Last updated

2008-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Psoriatic

Brief summary

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

Interventions

DRUGadalimumab

40 mg adalimumab eow Week 0 - Week 12

DRUGplacebo for adalimumab

placebo eow Week 0 - Week 12

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
ACR20	Week 12
Adverse Events	Throughout the Study

Secondary

Measure	Time frame
ACR50/70	Week 12
Modified Psoriatic Arthritis Response Criteria	Week 12
Multiple QOL Assessments	Week 12
Physicians Global Assessment for Psoriasis	Week 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026