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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00090129 |
The primary objective is to assess the safety and efficacy of an initial 12-week treatment course with onercept 150mg three times a week (TIW) for the induction of remission in subjects with moderate to severe plaque psoriasis, compared to matching placebo.
Condition | Intervention | Phase |
---|---|---|
Psoriatic Arthritis |
Drug: Onercept (r-hTBP-1) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase III Study of Subcutaneously Administered Onercept in the Treatment and Re-Treatment of Subjects With Moderate to Severe Plaque Psoriasis |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must fulfill all of the following criteria before randomization at Study Day 1:
Female subjects must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
[Confirmation that the subject is not pregnant must be established by a negative urinary hCG test within 7 days before SD1. A pregnancy test is not required if the subject is post-menopausal or surgically sterile.]
Exclusion Criteria:
To be eligible for inclusion in this study, the subjects must not meet any of the following criteria:
Inadequate bone marrow reserve, defined as:
In order to participate in this trial a subject must meet all of the inclusion and exclusion criteria specified above. Requests for protocol exceptions/exemptions must come from a participating, fully initiated site at which a prospective patient has consented to undergo screening by the Trial Director. There is no program in place to allow drug for a single patient IND, or for an expanded access protocol. This statement holds true for both children and adults.
Study ID Numbers: | 24979 |
Study First Received: | August 24, 2004 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00090129 |
Health Authority: | United States: Food and Drug Administration |
DLQI - Dermatology life quality index Plaque PASI – Psoriasis area and severity index TH1- medicated CD4+ |
CD8+ PGA- Physician’s Global Assessment PsA - Psoriatic arthritis |
Spinal Diseases Skin Diseases Arthritis, Psoriatic Joint Diseases Spondylarthropathy Quality of Life Bone Diseases |
Musculoskeletal Diseases Psoriasis Arthritis Spondylarthritis Skin Diseases, Papulosquamous Spondylarthropathies |