Clinical Trials Logo
  1. Home
  2. Axial Spondyloarthritis
  3. NCT02438787

A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis

Axial Spondyloarthritis Clinical Trial

Official title:
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Subjects With Active Radiographic Axial Spondyloarthritis

Clinical Trial Summary

The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.

Clinical Trial Description

This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study. The study consists of 3 phases; Screening (up to 8 weeks), Treatment phase: placebo-controlled (Week 0 to 24) and active treatment (Week 24 to Week 52), and Safety Follow-up (up to 12 weeks). Participants will be randomly assigned to 1 of 3 treatment groups: placebo, ustekinumab 45 mg and ustekinumab 90 mg. The total duration of study will be up to 64 weeks. Participants will be primarily assessed for Assessment of SpondyloArthritis International Society (ASAS) 40 response at Week 24. Participants' safety will be monitored throughout the trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02438787
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Terminated
Phase Phase 3
Start date July 31, 2015
Completion date August 31, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT05031767 - Remote Monitoring of Axial Spondyloarthritis N/A
Completed NCT05162937 - to Evaluate the Preliminary Efficacy and Safety of GR1501 Injection in Patients With Active Axial Spondyloarthritis Phase 2
Completed NCT03622658 - Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis Phase 2
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Terminated NCT02437162 - A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis Phase 3
Enrolling by invitation NCT06072859 - The Impact of Simulated Forest Immersion Therapy on Pain and Anxiety in Patients Axial Spondyloarthritis (axSpA) N/A
Completed NCT02552212 - Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS Phase 3
Active, not recruiting NCT01944163 - The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain N/A
Active, not recruiting NCT02687620 - Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
Completed NCT00844805 - Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) Phase 3
Terminated NCT02897115 - A Study Treating Participants With Early Axial Spondyloarthritis (axSpA) Taking an Intense Treatment Approach Versus Routine Treatment Phase 4
Completed NCT05019547 - The Turkish Version of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity
Recruiting NCT03738956 - Safety and Efficacy of Tofacitinib in the Treatment of NSAID Refractory Axial Spondyloarthritis:A Clinical Trial Phase 2/Phase 3
Completed NCT04679649 - Physiotherapy of Axial Spondyloarthritis N/A
Enrolling by invitation NCT02962479 - Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis? N/A
Completed NCT04485078 - Investigation of Central Sensitization Frequency and Related Factors in Axial Spondyloarthritis Patients
Recruiting NCT05812157 - Optimizing Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17 N/A
Completed NCT03039088 - PREDICT-SpA - French Epidemiological Study of the Evaluation of the Impact of Fibromyalgia in the TNF Alpha Treatment Effect in Axial Spondyloarthritis in Both Anti-TNF naïve and - Experienced Patients
Completed NCT04368494 - Exercise Therapy in Patients With Axial Spondyloarthritis N/A
Completed NCT03270501 - Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation Phase 3