Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01863732
Other study ID # CAIN457F2305E1
Secondary ID 2013-001089-40
Status Completed
Phase Phase 3
First received
Last updated
Start date November 6, 2013
Est. completion date March 16, 2018

Study information

Verified date June 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.


Recruitment information / eligibility

Status Completed
Enrollment 274
Est. completion date March 16, 2018
Est. primary completion date March 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: patients having completed the "core study" CAIN457F2305, indication for treatment extension. -- Exclusion Criteria: history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the "core study" CAIN457F2305.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Secukinumab
Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W
Other:
Placebo (Pbo)
Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W

Locations

Country Name City State
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Genk
Belgium Novartis Investigative Site Gent
Belgium Novartis Investigative Site Leuven
Bulgaria Novartis Investigative Site Burgas
Bulgaria Novartis Investigative Site Plovdiv
Bulgaria Novartis Investigative Site Plovdiv
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Sofia
Canada Novartis Investigative Site St. John's Newfoundland and Labrador
Canada Novartis Investigative Site Winnipeg Manitoba
France Novartis Investigative Site Bordeaux Cedex
France Novartis Investigative Site Limoges cedex Haute Vienne
France Novartis Investigative Site Paris
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Erlangen
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Herne
Germany Novartis Investigative Site Koeln
Germany Novartis Investigative Site Magdeburg
Germany Novartis Investigative Site Nürnberg
Italy Novartis Investigative Site Brescia BS
Italy Novartis Investigative Site Catania CT
Italy Novartis Investigative Site Palermo PA
Italy Novartis Investigative Site Siena SI
Italy Novartis Investigative Site Torino TO
Mexico Novartis Investigative Site Culiacan Sinaloa
Mexico Novartis Investigative Site Guadalajara Jalisco
Mexico Novartis Investigative Site Mexicali Baja California
Mexico Novartis Investigative Site Monterrey Nuevo Leon
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Utrecht
Peru Novartis Investigative Site Jesus Maria Lima
Peru Novartis Investigative Site La Victoria Lima
Peru Novartis Investigative Site Pueblo Libre Lima
Peru Novartis Investigative Site San Isidro Lima
Peru Novartis Investigative Site Surquillo Lima
Russian Federation Novartis Investigative Site Ekaterinburg
Russian Federation Novartis Investigative Site Ekaterinburg
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Saint Petersburg
Russian Federation Novartis Investigative Site Tula
Russian Federation Novartis Investigative Site Yaroslavl
Taiwan Novartis Investigative Site Kaohsiung
Taiwan Novartis Investigative Site Taichung Taiwan ROC
Turkey Novartis Investigative Site Gaziantep
Turkey Novartis Investigative Site Izmir
United Kingdom Novartis Investigative Site Cambridge
United Kingdom Novartis Investigative Site London England
United Kingdom Novartis Investigative Site Newcastle Upon Tyne
United Kingdom Novartis Investigative Site Wolverhampton
United States Novartis Investigative Site Duncansville Pennsylvania
United States Novartis Investigative Site Jackson Tennessee
United States Novartis Investigative Site Kingsport Tennessee
United States Novartis Investigative Site Portland Oregon
United States Novartis Investigative Site Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  France,  Germany,  Italy,  Mexico,  Netherlands,  Peru,  Russian Federation,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260 ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group. Week 104 to Week 260
Secondary Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260 ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group Week 104 to Week 260
See also
  Status Clinical Trial Phase
Completed NCT01208207 - A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108) Phase 3
Completed NCT02509026 - Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA Phase 4
Completed NCT02704845 - Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain N/A
Terminated NCT01209702 - A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs Phase 3
Terminated NCT01209689 - A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy Phase 3
Terminated NCT00766402 - An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs) Phase 4
Completed NCT00000433 - Blocking Tumor Necrosis Factor in Ankylosing Spondylitis Phase 2
Completed NCT00779012 - A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED) Phase 4
Completed NCT00779935 - Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED) Phase 4
Recruiting NCT05879419 - Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Phase 4
Completed NCT01567878 - Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects N/A
Completed NCT01188655 - Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis N/A
Completed NCT00760669 - An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants Phase 4
Completed NCT02159053 - 16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis Phase 3
Completed NCT00202865 - Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352) Phase 3
Completed NCT02374502 - Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial N/A
Terminated NCT00273858 - Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis N/A
Withdrawn NCT00298012 - Methotrexate in the Treatment of Axial Spondyloarthritis Phase 4
Completed NCT04810715 - Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis
Completed NCT03880968 - Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis