Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis (FIXTURE)
Phase 3
Completed
- Conditions
- Chronic Plaque Psoriasis
- Registration Number
- CTRI/2011/09/002026
- Lead Sponsor
- Novartis Healthcare Pvt Ltd
- Brief Summary
Purpose of the study:
This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
FPFV for India:30- Sep-2011
Enrolment target for India:120
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1264
Inclusion Criteria
- Patients with Behçets disease and with a history of recurrent uveitis in a least one eye.
- Documented evidence of Greater than22 recurrent exacerbations of either intermediate uveitis, posterior uveitis or panuveitis in the study eye within the past 6 months (this could include the current exacerbation for patients having an acute exacerbation at screening).
- Exacerbations fulfilling the study inclusion criteria must have one or more of the following recorded in the patients patients medical record for each recurrent exacerbation: Greater than 2 plus vitreous haze with less than 2plus anterior chamber cell grade (intermediate or posterior uveitis) or Greater than22 plus vitreous haze with Greater than22 plus anterior chamber cell grade (panuveitis) presence of retinal infiltrates or vasculitis or hemorrhages documented Greater than210 ETDRS letter or 2 line Snellen decrease in visual acuity attributed to ocular inflammation secondary to the recurrent exacerbation of Behçets disease.
- •Requirement for either of the following immunosuppressive therapies for at least 3 of the past 6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to Behçets disease: Prednisone or equivalent Greater than210 mg daily The need for at least Greater than21 periocular injection or Greater than21 intravitreal corticosteroid injection in the study eye within the past 6 months (the last injection must have not been given within 6 weeks of screening) Treatment with cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate either as monotherapy or in combination with or without steroids.
- (Patients treated at any time with chlorambucil or cyclophosphamide are not eligible for the study.) Patients not meeting the above specified criteria for immunomodulatory therapies are eligible for enrollment if they are intolerant to systemic immunomodulatory therapy as determined by the study investigator.
Exclusion Criteria
- Subjects with infectious uveitis, uveitis due to other causes than Behçets disease, or uveitis of unknown etiology.
- Less severe (i.e. anterior) uveitis associated with Behçets disease.
- Ocular treatments Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to study screening.
- Treatment with any injected or implantable corticosteroid releasing device (i.e., flucinolone acetonide implant, Retisert®) in the study eye within the last 3 years.
- Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle Systemic conditions or treatments Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster virus or measles) within 2 months prior to screening.
- Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening and no prior treatment with AIN457.
- Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis Measure: PASI (psoriasis area and severity index) and IGA (investigators global assessment) Time Frame: 12 wks
- Secondary Outcome Measures
Name Time Method 1.To determine if AIN457 can reduce the need for standard-of-care immuno suppressivemedications(ISM) in patients requiring systemic immunosuppression to treat/prevent posterior segment uveitis secondary to Behçets disease as measured by the ISM score
Trial Locations
- Locations (13)
Cuticare centre
🇮🇳Hyderabad, ANDHRA PRADESH, India
D.Y.Patil Medical college and Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Saples Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Durgabai Deshmukh hospital & Research Centre
🇮🇳Hyderabad, ANDHRA PRADESH, India
Father Muller Medical College Hospital
🇮🇳Bangalore, KARNATAKA, India
Kempegowda Institute of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
King George Hospital
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Lokmanya Tilak Municipal Medical College & General Hospital
🇮🇳Mumbai, MAHARASHTRA, India
M S Diabetes and Shridi Skin care centre
🇮🇳Bangalore, KARNATAKA, India
Osmania General hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
Scroll for more (3 remaining)Cuticare centre🇮🇳Hyderabad, ANDHRA PRADESH, IndiaDr Mir MubashirPrincipal investigator99866338629dr_mirs@hotmail.com