Spondylitis, Ankylosing Clinical Trial
Official title:
A Ph II/III Seamless, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Reduction in Signs and Symptoms and Inhibition of Structural Damage During Treatment With Tocilizumab Versus Placebo in Patients With Ankylosing Spondylitis Who Have Failed Non-steroidal Anti-inflammatory Drugs and Are naïve to TNF Antagonist Therapy NSAIDs
This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor necrsos factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for 12 weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4 mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week 208 for all patients. Anticipated time on study treatment is 208 weeks.
This study was planned as a Phase II/III seamless, multicenter, randomized, double-blind,
placebo-controlled study in patients with AS who were naïve to TNF antagonist therapy. The
study consisted of 2 parts, each preceded by a screening visit and followed by a common
open-label extension phase. Recruitment into Part 2 commenced after completion of enrollment
for Part 1.
Part 1 was designed as a Phase II study exploring the efficacy and safety of tocilizumab
therapy versus placebo. Part 1 was intended to determine whether Part 2 of the study would
continue, based on a Week 12 analysis.
Part 2 was designed to provide pivotal Phase III efficacy and safety data for tocilizumab in
patients with AS. Approximately 400 patients were to be enrolled. Once randomization into
Part 1 was complete, randomization into Part 2 of the study was to be initiated.
Based on the results of the Week 12 Part 1 analyses of the primary endpoint (ASAS20) and
secondary endpoints, and in consideration of all available safety data, a benefit/risk
assessment was made and it was decided to halt the study because of lack of overall
efficacy. Most patients did not complete the 24-week double-blind treatment period in Part
2.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
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 | |
Completed |
NCT01863732 -
Extension in AS: Sustainability of Benefits, Safety and Tolerability
|
Phase 3 | |
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 | |
Withdrawn |
NCT00298012 -
Methotrexate in the Treatment of Axial Spondyloarthritis
|
Phase 4 | |
Terminated |
NCT00273858 -
Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
|
N/A | |
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
|