Efficacy of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AIN457 (2x 10mg/kg)

Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.

Group Type EXPERIMENTAL

AIN457

Intervention Type BIOLOGICAL

The investigational drug, AIN457 50 mg lyophilizate vials was prepared by Novartis. Reconstitution of AIN457 with 1.2 mL SWFI produced a 47 mg/mL concentrate solution for infusion from which at least 1 mL was useable. The AIN457 concentrate was diluted in 5% glucose bags for infusion through a 0.2 micron in-line filter.

Placebo

Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Matching placebo to AIN457

Interventions

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AIN457

The investigational drug, AIN457 50 mg lyophilizate vials was prepared by Novartis. Reconstitution of AIN457 with 1.2 mL SWFI produced a 47 mg/mL concentrate solution for infusion from which at least 1 mL was useable. The AIN457 concentrate was diluted in 5% glucose bags for infusion through a 0.2 micron in-line filter.

Intervention Type BIOLOGICAL

Placebo

Matching placebo to AIN457

Intervention Type BIOLOGICAL

Eligibility 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No