Phase 3, multicenter, long-term extension study of 104 weeks in patients with axial spondyloarthritis

Phase 1

• Conditions: Axial Spondyloarthritis; MedDRA version: 19.0Level: LLTClassification code 10041672Term: Spondylitis ankylosingSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-002634-69-ES
• Lead Sponsor: illy S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-18
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 773

Inclusion Criteria

1.Have completed the final study visit in Study RHBV, RHBW, or RHBX. (Note: Patients from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a TNF inhibitor).
2.Must agree to use a reliable method of birth control.
3.Have given written informed consent.
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 675
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

-Have significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous ixekizumab study that, in the opinion of the investigator, pose an unacceptable risk to the patient if investigational product continues to be administered.
-Have a known hypersensitivity to ixekizumab or any component of this investigational product.
-Had investigational product permanently discontinued during a previous ixekizumab study.
-Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the patient’s participation in the study.
-Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol
-Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified