Rapid pain control in Ixekizumab targeted axial spondyloarthritis

Trial details

Who runs it

Universitaetsklinikum Erlangen AöR

Trial code

EU 2023-508976-12-00

Record updated

2024. január 29.

Original description

To evaluate early CNS pain response detected by BOLD signal changes in fMRI of the brain to Ixekizumab treatmentRead full original descriptionShow less

To evaluate early CNS pain response detected by BOLD signal changes in fMRI of the brain to Ixekizumab treatment

Inclusion: male or female subject aged ≥ 18 years at time of consent; negative pregnancy test in women of childbearing potential (WOCBP) and willing to use at least 1 acceptable method of contraception throughout trial participation and for at least 10 weeks after treatment period; understand and voluntarily sign informed consent form; able to follow trial instructions and likely to attend and complete all required visits; fulfils ASAS classification criteria for axSpA; BASDAI > 4; VAS pain (0 - 10) > 4; indication for systemic treatment with bDMARDs (active disease, inadequate response to 2 NSAIDs at maximum tolerable dosage); current NSAID and/or analgesic therapy at stable dose for at least 2 weeks prior to screening and maintenance for the duration of the trial (if applicable); current Glucocorticoids treatment (≤ 10 mg/day) at stable dose for at least 4 weeks prior to screening and maintenance for the duration of the trial (if applicable).

Exclusion: prior exposure to bDMARDs; treatment with Glucocorticoids of more than 10 mg/day; previous Ixekizumab treatment within 4 weeks (or 5 half-lives, whichever is longer) prior to enrolment; any severe active infection, e.g. hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon Tb-test. (if presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrolment) or history of recurrent infections; requirement for immunization with live vaccine during trial participation or within the four weeks prior to screening; history of or presence of inflammatory bowel disease including Crohn’s disease and ulcerative colitis; Clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, neurologic, gastrointestinal, immunologic, or other major diseases; Evidence of severe hepatic insufficiency defined as Child-Pugh score ≥ 10 (C); any other autoimmune or inflammatory disease (e.g. but not limited to RA, SLE, SSc, MCTD, Behcet disease, vasculitis, or autoimmune hepatitis); history of venous thrombosis or pulmonary embolism; Evidence of severe renal dysfunction defined as: eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1); any condition, including the presence of laboratory abnormalities, which would impact the safety of the subject or the interpretation of the trial results; any contraindication to perform MRI; presence of fibromyalgia or other forms of widespread pain at the discretion of the investigator.

EU CTIS 2023-508976-12-00