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Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis (CHAMPION)
This study has been completed.
Study NCT00235820   Information provided by Abbott
First Received: October 7, 2005   Last Updated: July 15, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

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 ]
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 ]
Safety parameters
 
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

 
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
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
271
 
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.
Both
18 Years and older
No
 
United States
 
 
NCT00235820
Beverly Papierello/Director, Clinical Program Management, Abbott
 
Abbott
 
Study Director: Global Medical Information Abbott
Abbott
June 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.