Study of efficacy and safety of secukinumab in patients with non-radiographic axial spondyloarthritis.
- Conditions
- on-radiographic axial spondyloarthritisMedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2015-001106-33-IT
- Lead Sponsor
- OVARTIS PHARMA SERVICES AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 555
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
- Male or non-pregnant, non-nursing female patients at least 18 years of age
- Diagnosis of axSpA according to ASAS axSpA criteria
- Objective signs of inflammation at screening, evident by Either MRI with Sacroiliac Joint inflammation OR hsCRP > ULN
- Active axSpA as assessed by total BASDAI = 4 cm (0-10 cm) at baseline
- Spinal pain as measured by BASDAI question #2 = 4 cm (0-10 cm) at baseline
- Total back pain as measured by VAS = 40 mm (0-100 mm) at baseline
- Patients should have been on at least 2 different NSAIDs at the
highest recommended dose for at least 4 weeks in total prior to randomization with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications
- Patients who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their axSpA therapy are required to be on a stable dose for at least 2 weeks before randomization
- Patients who have been on a TNFa inhibitor (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 prior to randomization or have been intolerant to at least one administration of an anti-TNFa agent
- Patients who have previously been on a TNFa inhibitor will be allowed entry into study after an appropriate wash-out period prior to randomization
- Patients taking MTX (= 25 mg/week) or sulfasalazine (= 3 g/day) are allowed to continue their medication and must have taken it for at least 3 months and have to be on a stable dose for at least
4 weeks prior to randomization
- Patients on MTX must be on stable folic acid supplementation before randomization
- Patients who are on a DMARD other than MTX or sulfasalazine must discontinue the DMARD 4 weeks prior to randomization, except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine washout has
been performed
- Patients taking systemic corticosteroids have to be on a stable dose of = 10 mg/day prednisone or equivalent for at least 2 weeks before randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 505
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
- Patients with radiographic evidence for sacroiliitis, grade = 2 bilaterally or grade = 3 unilaterally
- Inability or unwillingness to undergo MRI
- Chest X-ray or MRI with evidence of ongoing infectious or malignant process, obtained within 3 months of screening and evaluated by a qualified physician
- Patients taking high potency opioid analgesics
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
- 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
- hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes
- Any therapy by intra-articular injections within 4 weeks before randomization
- Any intramuscular corticosteroid injection within 2 weeks before randomization
- Patients previously treated with any biological
immunomodulating agents, except those targeting TNFa
- Patients who have taken more than one anti-TNFa agent
- Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents
- 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
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during entire study or longer if required by locally approved prescribing information
- Active ongoing inflammatory diseases other than axSpA that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis
- Underlying metabolic, hematologic, renal, hepatic, pulmonary,
neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy
- Significant medical problems or diseases, including but not limited to the following: uncontrolled hypertension (= 160/95 mmHg), congestive heart failure, uncontrolled diabetes, or very poor
functional status unable to perform self-care
- History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), alkaline phosphatase, or serum bilirubin.
- History of renal trauma, glomerulonephritis, or patients with one kidney only, or a serum creatinine level exceeding 1.5 mg/dL
- Screening total WBC count <3,000/µL, or platelets <100,000/µL or neutrophils 1,500/µL or hemoglobin <8.5 g/dL
- Active systemic infections during the last two weeks prior to randomization (exception: common cold)
- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by either a positive purified protein derivative (PPD) skin test or a positive QuantiFERON TB-Gold.
Patients with a positive test may participate in the study if further work up establishes
conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment according to local country guidelines must have been initiated
- Known infection with HIV virus,hepatitis B or hepatitis C at screening or randomization
- History of lymphoproliferative disease or any known malignancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method