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Rapid pain control in Ixekizumab targeted axial spondyloarthritis
EU CTIS ID: 2023-508976-12-00
What this study is testing
To evaluate early CNS pain response detected by BOLD signal changes in fMRI of the brain to Ixekizumab treatment
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- prior exposure to bDMARDs
- 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 renal dysfunction defined as: eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1)
- Evidence of severe hepatic insufficiency defined as Child-Pugh score ≥ 10 (C)
- treatment with Glucocorticoids of more than 10 mg/day
See the full eligibility criteria
- 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)
- prior exposure to bDMARDs
- 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 renal dysfunction defined as: eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1)
- Evidence of severe hepatic insufficiency defined as Child-Pugh score ≥ 10 (C)
- 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 contraindication to perform MRI
- 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
- any other autoimmune or inflammatory disease (e.g. but not limited to RA, SLE, SSc, MCTD, Behcet disease, vasculitis, or autoimmune hepatitis)
- presence of fibromyalgia or other forms of widespread pain at the discretion of the investigator
- requirement for immunization with live vaccine during trial participation or within the four weeks prior to screening
- history of venous thrombosis or pulmonary embolism
- any condition, including the presence of laboratory abnormalities, which would impact the safety of the subject or the interpretation of the trial results
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.