Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Abbott
Study ID
NCT00566722
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    Participants received an 80 mg adalimumab loading dose by subcutaneous injection at Baseline (Week 0). From Week 1 to Week 15, participants received 40 mg adalimumab by subcutaneous injection every other week.

Study Details

The objective of this study was to evaluate the safety and efficacy profile of Humira (adalimumab) in patients who had a sub-optimal response to prior systemic therapy. This open-label study was conducted in a patient population of moderate to severe chronic plaque psoriasis patients, which is an approved patient population for adalimumab.

Key Dates

Start date
Jan 31, 2008
Status verified
Apr 2011
Primary completion
Apr 30, 2009
Completion
Apr 30, 2009

Study Design

Enrollment
152 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label

Primary Outcome Measure

Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16 [ Time Frame: Week 16 ]

Locations (18)

FacilityCityStateZIPSite coordinators
Total Skin and Beauty Dermatology CentersBirminghamAlabama35205-
Dermatology Research of ArkansasLittle RockArkansas72205-
Therapeutics Clinical ResearchSan DiegoCalifornia92123-
Florida Academic Dermatology CentersMiamiFlorida33136-
Peachtree Dermatology AssociatesAtlantaGeorgia30327-
Dawes Fretzin Clinical Research GroupIndianapolisIndiana46256-
ORA Clinical Research and DevelopmentAndoverMassachusetts01810-
Mount Sinai School of MedicineNew YorkNew York10029-
New York University School of MedicineNew YorkNew York10016-
Montifiore Medical CenterThe BronxNew York10467-
Paddington Testing Co.PhiladelphiaPennsylvania19103-
Clinical PartnersJohnstonRhode Island02919-
Radiant ResearchGreerSouth Carolina29651-
Baylor Research InstituteDallasTexas75246-
Dermatology Treatment & Research Center, PA ResearchDallasTexas75230-
Center for Clinical StudiesHoustonTexas77058-
Virginia Clinical Research, Inc.NorfolkVirginia23507-
Dermatology AssociatesSeattleWashington98101-

Find similar trials in Birmingham, AL

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Total Skin and Beauty Dermatology Centers· Birmingham, ALDermatology Research of Arkansas· Little Rock, ARTherapeutics Clinical Research· San Diego, CAFlorida Academic Dermatology Centers· Miami, FLPeachtree Dermatology Associates· Atlanta, GADawes Fretzin Clinical Research Group· Indianapolis, IN

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