Phase 3
Completed N=730
Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
Source: ClinicalTrials.gov NCT00574249 ↗Enrolled (actual)
730
Serious AEs
4.3%
Results posted
Jan 2010
Primary outcomePrimary: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) — 70.9; 64.8 percentage of participants — p=0.086
Summary
The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) |
70.9; 64.8 | 0.086 |
| SECONDARY Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0) |
82.7; 80.9 | 0.565 |
| SECONDARY Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0) |
50.3; 38.8 | 0.002 sig |
| SECONDARY Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0) |
24.2; 15.3 | 0.003 sig |
| SECONDARY Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2 |
7.1; 13.9 | 0.004 sig |
| SECONDARY Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4 |
24.5; 33.1 | 0.011 sig |
| SECONDARY Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8 |
46.2; 42.9 | 0.413 |
| SECONDARY Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12 |
64.8; 50.0 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16 |
64.6; 56.6 | 0.028 sig |
| SECONDARY Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0) |
-71.46; -67.20 | 0.228 |
| SECONDARY Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0) |
-32.14; -47.49 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0) |
-46.64; -60.93 | 0.001 sig |
| SECONDARY Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0) |
-63.30; -62.30 | 0.764 |
| SECONDARY Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0) |
-69.49; -66.75 | 0.437 |
| SECONDARY Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0) |
20.53; 19.71 | 0.740 |
| SECONDARY Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0) |
19.35; 18.22 | 0.634 |
Eligibility Criteria
Inclusion Criteria
- Subject is >= 18 years of age
- Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis
- Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA
- Subject is judged to be in generally good health as determined by the principal investigator
Exclusion Criteria
- Subject has previous exposure to adalimumab
- Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
- Subject is taking or requires oral or injectible corticosteroids
- Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
- Subject considered by the investigator, for any reason, to be an unsuitable candidate
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
- Subject has a calcium metabolism disorder
Data sourced from ClinicalTrials.gov (NCT00574249). 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.