Phase 3
Completed N=147
Adalimumab in Adult Japanese Subjects With Psoriasis
Source: ClinicalTrials.gov NCT00647400 ↗Enrolled (actual)
147
Serious AEs
20.4%
Results posted
Jan 2010
Primary outcomePrimary: Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) — 78; 54; 80; 55 Participants
Summary
To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with psoriasis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) |
78; 54; 80; 55; 79; 52 | — |
| SECONDARY Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) |
54; 45; 69; 50; 65; 51 | — |
| SECONDARY Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) |
31; 29; 50; 39; 54; 44 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who completed Study M04-688 (NCT00338754)
Exclusion Criteria
- Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Data sourced from ClinicalTrials.gov (NCT00647400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.