2 year study of secukinumab (AIN457) treatment in patients with active Psoriatic Arthritis

• Conditions: Psoriatic arthritis; MedDRA version: 14.1Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-000276-34-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-29
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Male or non-pregnant, non-lactating female subjects at least 18 years of age 2. Diagnosis of PsA classified by CASPAR criteria (see Appendix 2) and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline =3 tender joints out of 78 and =3 swollen joints out of 76 (dactylitis of a digit counts as one joint each) 3. RF and anti-CCP antibodies negative. 4. Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of =2 cm diameter (but not in intertriginous areas such as armpits, or chest between breasts, or groin) or nail changes consistent with psoriasis or a documented history of plaque psoriasis. SEE PROTOCOL FOR MORE DETAILS
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 568
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

1. Chest X-ray with evidence of ongoing infectious or malignant process, obtained within 3 months of screening and evaluated by a qualified physician. 2. Subjects who have previously been treated with more than 3 different TNFa inhibitors (investigational or approved). 3 Subjects taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine). 4 Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa, investigational or approved. 5 Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor. 6 Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 and investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified