Primary: To evaluate the sustainability of subject benefits as quantified by the ASAS20 during long-term treatment.Secondary: ASAS40, safety and tolerability.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
ASAS20.
Secondary outcome
ASAS40, adverse events.
Background summary
This is an extension study for subjects who have completed the study
CAIN457F2305 (MEC 2011-184, NL37069.018.11, A randomized, double-blind,
placebo-controlled, multicenter study of secukinumab to demonstrate the
efficacy at 16 weeks and to assess the long term safety, tolerability and
efficacy up to 2 years in patients with active Ankylosing Spondylitis).
By joining the study subjects can continue treatment with secukinumab. In this
study the long term effects of the drug will be investigated. All subjects will
be treated with active study drug.
Study objective
Primary: To evaluate the sustainability of subject benefits as quantified by
the ASAS20 during long-term treatment.
Secondary: ASAS40, safety and tolerability.
Study design
Multicenter phase III parallel-group extension study. Double blind, unblinding
after 1st year.
Continuation of secukinumab dose during previous study:
• Secukinumab 75 mg (s.c. injections every 4 weeks)
• Secukinumab 150 mg (s.c. injections every 4 weeks)
Patients will, in principle, self-inject the drug with prefilled syringes.
Treatment period approx. 3 years.
Independent DSMB.
Approx. 300 patients.
Intervention
Treatment with secukinumab.
Study burden and risks
Risk: Adverse effects of study medication.
Burden: Study duration approx. 3 years. Approx. 16 visits. Duration max.3 h.
Fasting 6x.
Every 4 weeks 2 s.c. injections (1st year because of double-blind double-dummy
design) or 1 s.c. injection (after 1st year).
For those subjects who do not self-inject: approx. 25 extra short visits for
injection(s).
Every visit: physical examination, blood tests 5-30 ml/occasion, urine tests.
Every 6 months: ECG.
X rays spine: 1x.
MRI scan (subset of patients) 2x.
Questionnaires: visual analogue scales: disease activity, pain, BASFI, BASDAI,
FACIT-Fatigue, SF-36.
Raaposeweg 1
Arnhem 6824 DP
NL
Raaposeweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
Inclusion criteria
• Subjects must have completed the core study
• Subjects who are deemed by the investigator to benefit from continued secukinumab therapy
Exclusion criteria
• Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab during the core study
• Pregnancy, lactation.
• Women of childbearing potential who do not use adequate contraception.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-001089-40-NL |
| ClinicalTrials.gov | NCT01863732 |
| CCMO | NL45662.018.13 |