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Adalimumab in Adult Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis

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Abbott

Status and phase

Completed
Phase 3
Phase 2

Conditions

Psoriasis

Treatments

Drug: Human anti-TNF monoclonal antibody adalimumab/ up to 24 weeks

Study type

Interventional

Funder types

Industry

Identifiers

NCT00338754
M04-688

Details and patient eligibility

About

The purpose of the study is to assess the efficacy and safety of repeated administration of adalimumab in adult Japanese subjects with moderate to severe chronic plaque psoriasis.

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject was age 20 or older and in good health (Investigator discretion) with a recent stable medical history.
  • Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis

Exclusion criteria

  • Subject had previously received anti-TNF therapy.
  • Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVA, UVB or PUVA phototherapy
  • Subject is taking or requires oral or injectable corticosteroids
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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