Clinical trial NCT00809614: Efficacy of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis
Official title: Randomized, Double-blind Placebo-controlled Multi-center Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: Psoriatic arthritis
IgG1K monoclonal antibody
Interleukin -17A neutralizing
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis. The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses of AIN457 10 mg/kg administered three weeks apart.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of ACR Responders Per Treatment at Week 6
timeFrame: week 6
measure: Percentage of PsARC Responders Per Treatment at Week 6
timeFrame: week 6
Secondary outcomes:
measure: Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria
timeFrame: Day 8 and 15, Weeks 6, 8, 12, 16 and 24
measure: Percentage of Participants Who Achieved PsARC Response
timeFrame: Day 8 and 15, Weeks 6, 8, 12, 16 and 24
measure: Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment
timeFrame: Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24
measure: Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment
timeFrame: Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24
measure: SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment
timeFrame: Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24
measure: Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment
timeFrame: Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24
measure: Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment
timeFrame: Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24
measure: Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
timeFrame: Day 1 till end of the study (169)
measure: Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration
timeFrame: Day 1 till end of the study (169)
measure: Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2)
timeFrame: Day 1 till end of the study (169)
measure: Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)
timeFrame: Day 1 till end of the study (169)
measure: 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)
timeFrame: Day 1 till end of the study (169)
measure: Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)
timeFrame: Day 1 till end of the study (169)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Herne
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Amsterdamn
country: Netherlands
facility: Novartis Investigative Site
state: DE
city: Meerssen
country: Netherlands
facility: Novartis Investigative Site
state: KR
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Investigator Site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: