Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis

NCT ID: NCT01109940

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-12-31

Brief Summary

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of Intravenous infusion (IV) of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in ankylosing spondylitis a decision was taken to continue dosing for another 6 month period (Part 2).

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AIN457

Group Type: EXPERIMENTAL

AIN457A

Intervention Type: BIOLOGICAL

Interventions

AIN457A

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients who took part and completed in the core CAIN457A2209 study
• Patients who discontinued the core study due to unsatisfactory therapeutic effect at their Visit 14 (Week 16) or later could enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, provided that at their discontinuation visit they fulfilled either one of the criteria below. Patients who did not enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, were required to come for an additional baseline visit (Visit 17) and were required to fulfill either one of the criteria below:
• No improvement (compared with the core study baseline) in two out of the following four domains: patient global assessment, pain, BASFI and the mean of the two morning stiffness questions from the BASDAI. OR
• Deterioration (compared with the core study baseline) in one of the four domains (deterioration defined as >=20% worsening and an absolute worsening of >=1 unit)

Exclusion Criteria

• Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
• Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2209 study.
• Patients who discontinued from the core CAIN457A2209 study before Visit 14 (Week 16), and patients who completed the core study
• Pregnant or lactating women
• Presence of active infection
• Positive PPD or HIV test in patients where repeated testing was deemed appropriate due to their risk profile

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Paradise Valley, Arizona, United States

Novartis Investigative Site

Springfield, Illinois, United States

Novartis Investigative Site

Springfield, Illinois, United States

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Novartis Investigative Site

Duncansville, Pennsylvania, United States

Novartis Investigative Site

Jackson, Tennessee, United States

Novartis Investigative Site

Knoxville, Tennessee, United States

Novartis Investigative Site

Benbrook, Texas, United States

Novartis Investigative Site

Spokane, Washington, United States

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Herne, , Germany

Novartis Investigative Site

München, , Germany

Novartis Investigative Site

Amsterdamn, DE, Netherlands

Novartis Investigative Site

Newcastle upon Tyne, , United Kingdom

Countries

United States; Germany; Netherlands; United Kingdom

Other Identifiers

2009-011591-30

Identifier Type: -

Identifier Source: secondary_id

CAIN457A2209E1

Identifier Type: -

Identifier Source: org_study_id