Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646386

Enrollment

315

Registered

2008-03-28

Start date

2003-03-31

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 the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis

Interventions

DRUGadalimumab

40 mg eow Week 0 - Week 24

DRUGplacebo for adalimumab

40 mg eow Week 0 - Week 24

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 study participation
Sharp Score	Week 24

Secondary

Measure	Time frame
ACR20, 50, 70	Weeks 12, 24
Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI	Weeks 12 and 24

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026