Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00574249

Purpose

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

MedlinePlus related topics: Psoriasis

Drug Information available for: Calcipotriene Adalimumab Bentelan Betamethasone Betamethasone dipropionate

U.S. FDA Resources

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

Further study details as provided by Abbott:

Primary Outcome Measures:

PASI 75 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
PGA [ Time Frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
DLQI [ Time Frame: Change from Baseline in DLQI total score at weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
PASI [ Time Frame: Subjects who achieve PASI 50, 90 and 100 ] [ Designated as safety issue: No ]
SF-36 [ Time Frame: Weeks 8 and 16 ] [ Designated as safety issue: No ]

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

Detailed Description:

Additional information regarding sponsors: Abbott GmbH & Co. KG is sponsor for EU member states. Abbott US is sponsor for non-EU member states.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574249

Show 131 Study Locations

Sponsors and Collaborators

Abbott

More Information

No publications provided

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

Keywords provided by Abbott:

Psoriasis
Moderate Psoriasis
Severe Psoriasis
Chronic Plaque Psoriasis
Severe Chronic Plaque Psoriasis

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009