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

• Register: EUCTR
• Last refreshed on: 17 August 2015
• Main ID: EUCTR2011-000276-34-BE
• Date of registration: 20/10/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: 2 year study of secukinumab (AIN457) treatment in patients with active Psoriatic Arthritis
• Scientific title: A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active psoriatic arthritis
• Date of first enrolment: 16/12/2011
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000276-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Germany, Israel, Italy, Peru, Philippines, Poland, Russian Federation, Singapore, Slovakia, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
• Male or non-pregnant, non-lactating female patients at least 18 years of age
• Diagnosis of PsA classified by CASPAR criteri 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)
• 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
• Patients should have been on NSAIDs with an inadequate response
• Patients who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose
• Patients who have been on an anti-TNFa agent (not more than three) must have experienced an inadequate response

Other protocol-related inclusion criteria may apply.

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:
• Chest X-ray with evidence of ongoing infectious or malignant process
• Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
• Patients previously treated with any biological immunomodulating agents except for those targeting TNFa
• Previous treatment with any cell-depleting therapies

Other protocol-related exclusion criteria may apply.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Psoriatic arthritis
MedDRA version: 14.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Secukinumab
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To demonstrate the efficacy of secukinumab 75 or 150 mg at Week 24 is superior to placebo in patients with active PsA based on the proportion of patients achieving an ACR20 response in the subgroup of subjects who are TNFa inhibitor naïve.

Primary end point(s): ACR 20

Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Objective: • Proportion of subjects achieving an ACR20 response in the entire study population at Week 24.
• HAQ-DI in the subgroup of subjects who are TNFa inhibitor naïve at Week 24.
• Joint/bone structural damage (van der Heijde modified total Sharp score) in the subgroup of subjects who are TNFa inhibitor naïve at Week 24.
• Proportion of subjects achieving Major Clinical Response at Week 52 in the subgroup of subjects who are TNFa inhibitor naïve at Week 52.

Secondary Outcome(s)

Secondary end point(s): - HAQ-DI, and van der Heijde modified total Sharp Score
- Major clinical response

Timepoint(s) of evaluation of this end point: Respectively:
- 16 weeks
- 52 weeks

Secondary ID(s)

CAIN457F2306

2011-000276-34-CZ

Source(s) of Monetary Support

Novartis Pharma AG