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Sponsored by: |
Abbott |
---|---|
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00574249 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Plaque Psoriasis |
Drug: adalimumab Drug: Calcipotriol + Betamethasone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment |
Enrollment: | 730 |
Study Start Date: | November 2007 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: adalimumab
Soft Capsule (sc)
Drug: Calcipotriol + Betamethasone
Topical
|
2: Placebo Comparator |
Drug: adalimumab
Soft Capsule (sc)
Drug: Calcipotriol + Betamethasone
Topical
|
Additional information regarding sponsors: Abbott GmbH & Co. KG is sponsor for EU member states. Abbott US is sponsor for non-EU member states.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Abbott ( Marie Rosenfeld, Senior CRM ) |
Study ID Numbers: | M10-060 |
Study First Received: | December 12, 2007 |
Last Updated: | March 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00574249 History of Changes |
Health Authority: | Turkey: Ethics Committee |
Psoriasis Moderate Psoriasis Severe Psoriasis Chronic Plaque Psoriasis Severe Chronic Plaque Psoriasis |
Betamethasone-17,21-dipropionate Anti-Inflammatory Agents Skin Diseases Hormone Antagonists Betamethasone sodium phosphate Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Adalimumab |
Glucocorticoids Hormones Calcipotriene Sodium phosphate Psoriasis Antirheumatic Agents Skin Diseases, Papulosquamous Betamethasone |
Betamethasone-17,21-dipropionate Anti-Inflammatory Agents Respiratory System Agents Skin Diseases Betamethasone sodium phosphate Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Adalimumab Hormones |
Glucocorticoids Pharmacologic Actions Calcipotriene Psoriasis Therapeutic Uses Antirheumatic Agents Dermatologic Agents Skin Diseases, Papulosquamous Betamethasone |