- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00645892
Extension Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
March 25, 2008 updated by: Abbott
Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject participated and relapsed in prior PS study
Exclusion Criteria:
- Subject has other active skin diseases
- Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
- Poorly controlled medical conditions
- History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease.
- History of cancer or lymphoproliferative disease
- History of active TB or listeriosis, or persistent chronic or active infections
- Known to have immune deficiency or is immunocompromised
- Clinically significant abnormal laboratory test results
- Erythrodermic psoriasis or generalized pustular psoriasis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
|
OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded 40 mg eow through Week 24
Other Names:
|
Placebo Comparator: B
|
OL 80 mg at Weeks 0 and 1, 40 mg weekly Week 2 - Week 11, blinded placebo eow through Week 24
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Psoriasis Area and Severity Index
Time Frame: Week 12
|
Week 12
|
Adverse Events
Time Frame: Throughout Study Participation
|
Throughout Study Participation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Psoriasis Area and Severity Index
Time Frame: Week 12, Week 24
|
Week 12, Week 24
|
Physician's Global Assessment
Time Frame: Week 12, Week 24
|
Week 12, Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Primary Completion (Actual)
September 1, 2004
Study Registration Dates
First Submitted
March 25, 2008
First Submitted That Met QC Criteria
March 25, 2008
First Posted (Estimate)
March 28, 2008
Study Record Updates
Last Update Posted (Estimate)
March 28, 2008
Last Update Submitted That Met QC Criteria
March 25, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M03-596
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis
-
ProgenaBiomeRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Face | Psoriasis Nail | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaUnited States
-
Clin4allRecruitingPsoriasis of Scalp | Psoriasis Nail | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrance
-
Innovaderm Research Inc.CompletedScalp Psoriasis | Pustular Palmo-plantar Psoriasis | Non-pustular Palmo-plantar Psoriasis | Elbow Psoriasis | Lower Leg PsoriasisCanada
-
Centre of Evidence of the French Society of DermatologyRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Palmaris | Psoriatic Erythroderma | Psoriatic Nail | Psoriasis Guttate | Psoriasis Inverse | Psoriasis PustularFrance
-
UCB Biopharma S.P.R.L.CompletedModerate to Severe Psoriasis | Generalized Pustular Psoriasis and Erythrodermic PsoriasisJapan
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
-
TakedaRecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Janssen Pharmaceutical K.K.RecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Eli Lilly and CompanyCompletedGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Shanghai Huaota Biopharmaceutical Co., Ltd.RecruitingGeneralized Pustular Psoriasis (GPP)China
Clinical Trials on adalimumab
-
PfizerCompletedHealthyUnited States, Belgium
-
PfizerCompletedHealthy SubjectsUnited States
-
AbbottCompletedArthritis, Juvenile IdiopathicUnited States, Belgium, Czech Republic, France, Germany, Italy, Slovakia, Spain
-
Shanghai Henlius BiotechCompleted
-
AbbottCompleted
-
Turgut İlaçları A.Ş.CompletedHealthy ParticipantsGermany
-
Mylan Inc.Mylan GmbHCompletedPsoriasis | Arthritis, PsoriaticBulgaria, Estonia, Hungary, Poland, Russian Federation, Ukraine
-
AbbottCompletedRheumatoid ArthritisSpain
-
SandozHexal AGCompletedPlaque Type PsoriasisUnited States, France, Bulgaria, Slovakia