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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00809614 |
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Date of registration:
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16/12/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis
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Scientific title:
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Randomized, Double-blind Placebo-controlled Multi-center Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Psoriatic Arthritis |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00809614 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Netherlands
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United Kingdom
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Contacts
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Name:
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Novartis |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Investigator Site |
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A diagnosis of psoriatic arthritis
Exclusion Criteria:
- Patients with arthritis or ankylosing spondyitis
- Drug-induced psoriasis
- Male or female patients who plan to conceive during the time course of the study, or
for 6 months after the administration of the second dose.
- Participation in any clinical trial within 4 weeks prior to initial dosing or longer.
- Previous use of immunosuppressive agents eg cyclosporine, without the necessary
wash-out period
- History of severe allergy to food or drugs
- Positive TB test. Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psoriatic Arthritis
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Intervention(s)
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Biological: Placebo
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Biological: AIN457
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Primary Outcome(s)
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Percentage of ACR Responders Per Treatment at Week 6
[Time Frame: week 6]
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Percentage of PsARC Responders Per Treatment at Week 6
[Time Frame: week 6]
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Secondary Outcome(s)
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Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
[Time Frame: Day 1 till end of the study (169)]
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Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)
[Time Frame: Day 1 till end of the study (169)]
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Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment
[Time Frame: Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24]
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Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment
[Time Frame: Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24]
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Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)
[Time Frame: Day 1 till end of the study (169)]
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Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2)
[Time Frame: Day 1 till end of the study (169)]
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PK of AIN457: Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)
[Time Frame: Day 1 till end of the study (169)]
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Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment
[Time Frame: Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24]
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Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment
[Time Frame: Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24]
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Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria
[Time Frame: Day 8 and 15, Weeks 6, 8, 12, 16 and 24]
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SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment
[Time Frame: Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24]
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Percentage of Participants Who Achieved PsARC Response
[Time Frame: Day 8 and 15, Weeks 6, 8, 12, 16 and 24]
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Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration
[Time Frame: Day 1 till end of the study (169)]
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Secondary ID(s)
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CAIN457A2206
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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