Phase 4
Completed N=50
An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation
Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT01644396 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24 — 82.0 percentage of participants
Summary
This is an open-label study designed to establish the safety and effectiveness of adalimumab in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24 |
82.0 | — |
| SECONDARY Percentage of Participants Achieving a Physician's Global Assessment of Clear |
0; 0; 6.0; 20.0; 60.0; 70.0 | — |
| SECONDARY Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal |
2.0; 12.0; 34.0; 72.0; 86.0; 80.0 | — |
| SECONDARY Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA) |
40.0; 74.0; 98.0; 98.0; 100; 96.0 | — |
| SECONDARY Percentage of Participants Achieving a PASI 50 Response |
8.0; 36.0; 84.0; 88.0; 94.0; 96.0 | — |
| SECONDARY Percentage of Participants Achieving a PASI 75 Response |
0; 4.0; 44.0; 76.0; 82.0 | — |
| SECONDARY Percentage of Participants Achieving a PASI 90 Response |
0; 0; 20.0; 48.0; 72.0; 76.0 | — |
| SECONDARY Percentage of Participants Achieving a PASI 100 Response |
0; 0; 2.0; 20.0; 50.0; 64.0 | — |
| SECONDARY Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score |
-20.42; -45.75; -69.28; -81.74; -89.42; -91.18 | — |
| SECONDARY Percent Change From Baseline in Dermatology Life Quality Index (DLQI) |
-60.04; -75.03; -79.16 | — |
| SECONDARY Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) |
-68.06 | — |
Eligibility Criteria
Inclusion Criteria
A patient will be eligible for study participation if he/she meets the following criteria:
- Male and female patients ≥ 18 years of age.
- Clinical diagnosis of psoriasis for at least 6 months as determined by patient interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator.
- Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as determined by patient interview of his/her medical history.
- Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Baseline visit.
- PASI (Psoriasis Area and Severity Index) score ≥ 10 at the Baseline visit.
Exclusion Criteria
- Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or medication-exacerbated psoriasis or new onset of guttate psoriasis.
- Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
- Patient who cannot discontinue topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids at least 14 days prior to the Baseline (Week 0) visit and during the study. Participants are allowed to use:
- Shampoos that contain no corticosteroid;
- Bland (without beta or alpha hydroxy acids or containing no psoriasis treatment) emollients;
- Low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
- Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior to the Baseline (Week 0) visit and during the study.
- Patient who cannot avoid PUVA (psoralen + ultraviolet A) phototherapy for at least 28 days prior to the Baseline (Week 0) visit and during the study.
Data sourced from ClinicalTrials.gov (NCT01644396). 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.