None listed
Conditions
Interventions
A SCREENING (SCR) PEROD RUNNING 4 WEEKS BEFORE RANDOMIZATION WILL BE USED TO ASSESS ELIGIBILITY FOLLOWED BY A TREATMENT PERIOD OF 2 YEARS. AT BASELINE (BSL), SUBJECTS WHOSE ELIGIBILITY IS CONFIRMED WI
INHIBITOR INCOMPLETE RESPONDERS (TNF-IR) OR TNFα
INHIBITOR NAIVE SUBJECTS.
APPROXIMATELY 30% OF SUBJECTS HAVE TO BE TNF-IR TO ENSURE A REPRESENTATIVE POPULATION FOR THE ASSESSMENT OF EFFICACY AND SAFETY.
AT WEEK 16 (VISIT 8), EFFICACY OF SECUK
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. PATIENT 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. 2. MALE OR NON-PREGNANT, NON-LACTATING FEMALE PATIENTS AT LEAST 18 YEARS OF AGE. 3. DIAGNOSIS OF MODERATE TO SEVERE AS WITH PRIOR DOCUMENTED RADIOLOGIC EVIDENCE (X-RAY) FULFILLING THE MODIFIED NEW YORK CRITERIA FOR AS (APPENDIX 3) WITH ACTIVE AS AND A BASDAI ≥ 4 (0-10) AND SPINAL PAIN AS MEASURED BY VAS ≥ 4 CM AT BASELINE. 4. PATIENTS SHOULD HAVE BEEN ON NSAIDs AT THE HIGHEST RECOMMENDED DOSE FOR AT LEAST 3 MONTHS WITH AN INADEQUATE RESPONSE OR FAILURE TO RESPOND, OR LESS THAN 3 MONTHS IF THERAPY HAD TO BE WITHDRAWN DU TO INTOLERANCE, TOXICITY OR CONTRAINDICATIONS. 5. PATIENTS WHO ARE REGULARLY TAKING NSAIDs (COX-1 or COX-2 INHIBITORS) AS PART OF THEIR THERAPY AS THERAPY ARE REQUIRED TO BE ON A STABLE DOSE FOR AT LEAST 2 WEEKS BEFORE RANDOMIZATION. 6. PATIENTS WHO HAVE BEEN ON AN ANTI-TNFα AGENT (NOT MORE THAN ONE) MUST HAVE EXPERIENCED AN INADEQUATE RESPONSE TO PREVIOUS OR CURRENT TREATMENT GIVEN AT AN APPROVED DOSE FOR AT LEAST 3 MONTHS OR HAVE BEEN INTOLERANT TO AT LEAST ONE ADMINISTRATION OF AN ANTI-TNFα AGENT.
Exclusion criteria
Exclusion criteria: 1. CHEST X-RAY WITH EVIDENCE OF ONGOING INFECTIOUS OR MALIGNANT PROCESS, OBTAINED WITHIN 3 MONTHS OF SCREEING AND EVALUATED BY A QUALIFIED PHYSICIAN. 2. PATIENTS WITH TOTAL ANKYLOSIS OF THE SPINE. 3. PATIENTS TAKING HIGH POTENCY OPIOID ANALGESICS (e.g., METHADONE, HYDROMORPHONE, OR MORPHINE). 4. PREVIOUS EXPOSURE TO SECUKINUMAB OR ANY OTHER BIOLOGIC DRUG DIRECTLY TARGETING IL-17 OR IL-17 RECEPTOR. 5. USE OF ANY INVESTIGATIONAL DRUG AND/OR DEVICES WITHIN 4 WEEKS OF RANDOMIZATION, OR A PERIOD OF 5 HALF-LIVES OF THE INVESTIGATIONAL DRUG, WHICHEVER IS LONGER. 6. HISTORY OF HYPERSENSITIVITY TO THE STUDY DRUG OR ITS EXCIPIENTS OR TO DRUGS OF SIMILAR CHEMICAL CLASSES. 7. ANY THERAPY BY INTRA-ARTICULAR INJECTIONS (e.g., CORTICOSTEROID) WITHIN 4 WEEKS BEFORE RANDOMIZATION. 8. ANY INTRAMUSCULAR CORTICOSTEROID INJECTION WITHIN 2 WEEKS BEFORE RANDOMIZATION. 9. PATIENTS PREVIOUSLY TREATED WITH BIOLOGICAL INMUNOMODULATING AGENTS EXCEPT FOR THOSE TARGETING TNFα
Countries
Bulgaria, Netherlands, United Kindgdom
Contacts
Public ContactAlexandra Lopez
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed