Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Abbott
Study ID
NCT00735787
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — BIOLOGICAL
    Loading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
  • Adalimumab — BIOLOGICAL
    Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.

Study Details

Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.

Key Dates

Start date
Aug 31, 2008
Status verified
Oct 2010
Primary completion
Sep 30, 2009
Completion
Sep 30, 2009

Study Design

Enrollment
81 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo/Adalimumab
    Loading dose of 2 placebo injections at Week 0 and placebo injections every other week (eow) from Week 1 through Week 15. In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
  • Active Comparator: Adalimumab
    80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 15. For subjects who continued in the second period of the study, subjects received 2 placebo injections at Week 16 to maintain the blind. Open-label 40 mg adalimumab eow was administered from Week 17 through Week 27.

Primary Outcome Measure

Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 [ Time Frame: Week 16 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 10168Little RockArkansas72205-
Site Reference ID/Investigator# 10005BakersfieldCalifornia93309-
Site Reference ID/Investigator# 10003MaconGeorgia31217-
Site Reference ID/Investigator# 10171St LouisMissouri63117-
Site Reference ID/Investigator# 10164East WindsorNew Jersey08520-
Site Reference ID/Investigator# 10173DallasTexas75246-1613-
Site Reference ID/Investigator# 11302HoustonTexas77030-
Site Reference ID/Investigator# 10166San AntonioTexas78258-

Find similar trials in Little Rock, AR

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Site Reference ID/Investigator# 10168· Little Rock, ARSite Reference ID/Investigator# 10005· Bakersfield, CASite Reference ID/Investigator# 10003· Macon, GASite Reference ID/Investigator# 10171· St Louis, MOSite Reference ID/Investigator# 10164· East Windsor, NJSite Reference ID/Investigator# 10173· Dallas, TX

Related Studies