Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis (FUTURE 1 ext)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01892436
First received: July 1, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

This study is designed as a 3-year extension to the phase III core study CAIN457F2306. It aims to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects will complete the assessments associated with the core study visit and will subsequently continue in the extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity will ensure that subjects who are experiencing worsening of disease in any of the treatment groups can exit the study upon their own wish or based on the advice of the investigator at any time.


Condition Intervention Phase
Psoriatic Arthritis
Drug: Secukinumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • ACR 20, 50 , 70 [ Time Frame: Over the entire duration of the study up to Week 260 ] [ Designated as safety issue: No ]
    Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 (or ACR50 or ACR 70) criteria if he/she has at least 20 % (or 50% or 70%) improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: o Patient's assessment of RA pain o Patient's global assessment of disease activity o Physician's global assessment of disease activity o Subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score) o Acute phase reactant (hsCRP or ESR)


Secondary Outcome Measures:
  • Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Over the entire duration of the study up to Week 260 ] [ Designated as safety issue: No ]
    Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.

  • Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Over the entire duration of the study up to Week 260 ] [ Designated as safety issue: No ]
    Proportion of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.

  • Change from baseline in DAS28 [ Time Frame: Over the entire duration of the study up to Week 260 ] [ Designated as safety issue: No ]
    Changes in DAS28 (utilizing hsCRP) from baseline to over entire study duration up to Month 60. The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission.

  • Subjects achieving low disease activity and disease remission [ Time Frame: Over the entire duration of the study up to Week 260 ] [ Designated as safety issue: No ]
    Proportion of subjects achieving low disease activity (DAS28 ≤ 3.2) and disease remission (DAS28 < 2.6). The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission

  • Safety and tolerability [ Time Frame: Over the entire duration of the study ] [ Designated as safety issue: Yes ]
    Adverse events, vital signs, clinical laboratory variables, ECG


Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secukinumab 75mg
Subjects will continue to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256.
Drug: Secukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
Other Name: AIN457
Experimental: Secukinumab 150mg
Subjects will continue to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256.
Drug: Secukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
Other Name: AIN457

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
  • Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
  • Subjects must be deemed by the investigator to benefit from continued secukinumab therapy

Exclusion criteria

  • Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
  • Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892436

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 107 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01892436     History of Changes
Other Study ID Numbers: CAIN457F2306E1, 2013-001241-13
Study First Received: July 1, 2013
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Extension study, psoriatic arthritis, pre-filled syringe

Additional relevant MeSH terms:
Arthritis, Psoriatic
Arthritis
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014