Health Condition 1: null- Rheumatoid Arthritis
Conditions
Interventions
Intervention1: secukinumab 150mg s.c. every 4 weeks
: Biological: Secukinumab (AIN457).
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to uniqu
Sponsors
Novartis Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: > > Subjects must give a written informed consent before any assessment is performed. > > Subjects must have completed the 104-week treatment period in the core study > > Subjects who are deemed by the investigator to benefit from continued secukinumab therapy.
Exclusion criteria
Exclusion criteria: 1. Use of other investigational drugs except for secukinumab during the core study. 2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. 3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. 4.Any subject who is deemed not to be benefiting from the study drug based upon lack of improvement or worsening of their symptoms. 5. Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab during the core study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response by American College of Rheumatology response criteria [Designated as safety issue: No] Improvement in RA signs and symptoms by response criteria established by the American College of Rheumatology (ACR20, ACR50, and ACR70) Timepoint: Response by American College of Rheumatology response criteria [Designated as safety issue: No] Improvement in RA signs and symptoms by response criteria established by the American College of Rheumatology (ACR20, ACR50, and ACR70) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the van der Heijde total modified Sharp score relative to baseline [Designated as safety issue: No] The van der Heijde total modified Sharp score enumerates features of joint damage and articular destruction measured from erosions and joint space narrowing observed on X-rays of the hands and feet. Timepoint: Time Frame: every 12 months;Functional ability and activity restriction measure, HAQ-DI. [Designated as safety issue: No] HAQ-DI includes questions about upper extremities, lower extremities, and activities that involve both. There are 20 questions about difficulty of dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Timepoint: Time Frame: every 3 months;Proportion of subjects achieving ACR/EULAR remission. [Designated as safety issue: No] ACR/EULAR remission is defined as SDAI â?¤ 3.3, where SDAI is a measure of disease activity in RA based on 28 tender and swollen joint counts, CRP, Physician and Patients Global Assessments of Disease. Timepoint: Time Frame: every 3 months;Proportion of subjects achieving Low Disease Activity and good/moderate EULAR responses. [Designated as safety issue: No] Low Disease Activity is defined as DAS28 â?¤ 3.2. EULAR good response requires an improvement of greater than 1.2 in the DAS28 score with a present score of â?¤3.2; EULAR moderate response is defined as an improvement of greater than 0.6 to â?¤1.2 in DAS28 and a present score of â?¤5.1; or an improvement of greater than 1.2 and a present score of greater than 3.2.Timepoint: Time Frame: every 3 months;Safety and tolerability. [Designated as safety issue: Yes] Treatment emergent adverse events, including serious adverse events will be reported according to their percentages in the trial population and to their incidence per 100 subject years of exposure. Laboratory result and vital signs summaries for the subject population will be reported according to mean values and values outside of normal ranges. Timepoint: Time F | — |
Countries
Argentina, Belgium, Canada, Colombia, Guatemala, Hungary, India, Italy, Japan, Mexico, Panama, Thailand, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed