October 7, 2005 |
July 15, 2008 |
July 2005 |
- Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- Safety parameters [ Time Frame: Every Study Visit ] [ Designated as safety issue: Yes ]
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Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score. |
Complete list of historical versions of study NCT00235820 on ClinicalTrials.gov Archive Site |
- Physician Global Assessment [ Time Frame: Baseline - Week 16 ] [ Designated as safety issue: No ]
- PASI 50/90/100 [ Time Frame: Baseline - Week 16 ] [ Designated as safety issue: No ]
- DLQI [ Time Frame: Baseline - Week 16 ] [ Designated as safety issue: No ]
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Safety parameters |
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Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis |
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Phase III |
Interventional |
Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Psoriasis |
- Drug: adalimumab
- Drug: MTX
- Drug: placebo adalimumab, placebo MTX
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Completed |
271 |
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May 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis
- Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents.
- Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections.
- Male subjects must hve been vasectomized or practicing birth control.
Exclusion Criteria:
- Previous systemic anti-TNF therapy.
- Prior use of MTX.
- Known hypersensitivity to the constituents of adalimumab.
- Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment.
- Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
- Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline.
- Use of PUVA for at least 4 weeks prior to Baseline.
- Use of oral or injectable corticosteroids during the study.
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Female subject who is pregnant or breast feeding or considering becoming pregnant.
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Both |
18 Years and older |
No |
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United States |
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NCT00235820 |
Beverly Papierello/Director, Clinical Program Management, Abbott |
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Abbott |
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Study Director: |
Global Medical Information |
Abbott |
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Abbott |
June 2008 |