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

NCT00809614 | Completed Phase 2 Results

• 1 other identifier: CAIN457A2206
• Study Type: interventional
• Target: 42
• Locations: 3 countries
• Sites: 10

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.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic arthritis; IgG1K monoclonal antibody; Interleukin -17A neutralizing

Outcome Measures

Primary Outcomes (2)

• Percentage of ACR Responders Per Treatment at Week 6

  A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)

  week 6

• Percentage of PsARC Responders Per Treatment at Week 6

  Psoriatic Arthritis Response Criteria (PsARC) includes measures of tender and swollen joint counts, patient's assessment of pain, physician's and patient's global assessment of disease activity A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)

  week 6

Secondary Outcomes (13)

• Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria

  Day 8 and 15, Weeks 6, 8, 12, 16 and 24

• Percentage of Participants Who Achieved PsARC Response

  Day 8 and 15, Weeks 6, 8, 12, 16 and 24

• Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment

  Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24

• Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment

  Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24

• SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment

  Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24

Study Arms (2)

AIN457 (2x 10mg/kg)

EXPERIMENTAL

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

Biological: AIN457

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

AIN457 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.

AIN457 (2x 10mg/kg)

Placebo BIOLOGICAL

Matching placebo to AIN457

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of psoriatic arthritis

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Berlin, 12203, Germany

Location

Novartis Investigative Site

Hamburg, 22081, Germany

Location

Novartis Investigative Site

Hamburg, 22415, Germany

Location

Novartis Investigative Site

Herne, 44649, Germany

Location

Novartis Investigative Site

München, 80336, Germany

Location

Novartis Investigative Site

Amsterdamn, DE, 1100, Netherlands

Location

Novartis Investigative Site

Meerssen, KR, 6231, Netherlands

Location

Novartis Investigative Site

Glasgow, G12 8TA, United Kingdom

Location

Novartis Investigative Site

Leeds, LS7 4SA, United Kingdom

Location

Novartis Investigative Site

Newcastle upon Tyne, NE2 4HH, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis

  Novartis Investigator Site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 13, 2015
• Results First Posted: November 13, 2015

Record last verified: 2015-10

Locations

NL (2); DE (5); GB (3)