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

Novartis

Status and phase: Completed; Phase 2

Conditions: Psoriatic Arthritis

Treatments: Biological: AIN457; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00809614

CAIN457A2206

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

AIN457 (2x 10mg/kg)

Experimental group

Description:

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

Treatment:

Biological: AIN457

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo