Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Abbott
Study ID
NCT00918255
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
  • Placebo — DRUG
    Subcutaneous injection using prefilled syringe containing 0.8 milliliters

Study Details

This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.

Key Dates

Start date
Apr 30, 2009
Status verified
Apr 2011
Primary completion
Mar 31, 2010
Completion
Nov 30, 2010

Study Design

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

Arms

  • Experimental: Adalimumab 40 mg qwk
    Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
  • Experimental: Adalimumab 40 mg eow
    Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
  • Placebo Comparator: Placebo
    Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.

Primary Outcome Measure

Percentage of Participants Achieving Clinical Response at Week 16 [ Time Frame: Baseline, Week 16 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Site Ref # / Investigator 19062BirminghamAlabama35205-
Site Ref # / Investigator 18201BakerfieldCalifornia93309-
Site Ref # / Investigator 18467Los AngelesCalifornia90045-
Site Ref # / Investigator 18207San DiegoCalifornia92103-
Site Ref # / Investigator 18204MiamiFlorida33136-
Site Ref # / Investigator 18209AtlantaGeorgia30327-
Site Ref # / Investigator 18202SkokieIllinois60077-
Site Ref # / Investigator 18211EvansvilleIndiana47714-
Site Ref # / Investigator 18203BostonMassachusetts02111-
Site Ref # / Investigator 18210BostonMassachusetts02114-
Site Ref # / Investigator 18461St LouisMissouri63104-
Site Ref # / Investigator 18466OmahaNebraska68144-
Site Ref # / Investigator 18208New YorkNew York10019-
Site Ref # / Investigator 19141New YorkNew York10016-
Site Ref # / Investigator 19001Winston-SalemNorth Carolina27103-
Site Ref # / Investigator 18981HersheyPennsylvania17033-
Site Ref # / Investigator 18464PhiladelphiaPennsylvania19104-
Site Ref # / Investigator 19061DallasTexas75246-1613-
Site Ref # / Investigator 18463San AntonioTexas78258-
Site Ref # / Investigator 18206NorfolkVirginia23507-

Find similar trials in Birmingham, AL

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Site Ref # / Investigator 19062· Birmingham, ALSite Ref # / Investigator 18201· Bakerfield, CASite Ref # / Investigator 18467· Los Angeles, CASite Ref # / Investigator 18207· San Diego, CASite Ref # / Investigator 18204· Miami, FLSite Ref # / Investigator 18209· Atlanta, GA

Related Studies