ixekizumab for Axial spondyloarthritis | Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- Inclusion criteria for both groups \tAge ≥ 18 years at the time of consent. \tClinical indication for a biologic drug as assessed by the treating physician. \tSufficient contraception for women. Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol.\n- Inclusion criteria for patients with axSpA •\tAxSpA according to ASAS classification criteria for axSpA •\tActive inflammation on MRI of the SIJs and/or spine as evaluated by a central SpA imaging expert and/or radiographic modified New York criteria fulfilled as judged by a central SpA imaging expert. •\tTotal back pain as measured on a VAS scale ≥ 40 mm (0-100 mm) at baseline.\n- Inclusion criteria for patients with PsA •\tPsA according to CASPAR criteria. •\tNegative rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP). •\tFor patients with axial PsA involvement: o\tImaging documented axial involvement on MRI, X-ray, or low-dose CT as judged by a central SpA imaging expert. •\tA minimum of 1 tender and swollen joint in addition to 2 further anatomical localizations with clinical signs of inflammation (i.e., tender enthesis and/or tender and/or swollen joint) assessed at screening and baseline."}

Exclusion criteria

• {"criterion_text":"- Contraindications for ixekizumab.\n- Contraindication for MRI.\n- Previous exposure to ixekizumab or other biologic drug directly targeting IL-17 or IL-17 receptor\n- Has received more than 1 prior anti-TNF inhibitor\n- Previous exposure to other types of bDMARDs than TNF inhibitor.\n- Active inflammatory bowel disease\n- DMARDs are allowed during the study, but the dose cannot be changed from 1 month before the first MRI.\n- Use of any investigational drug and/or devices within 1 month before randomization or a period of 5 half-lives of the investigational drug, whichever is longer.\n- Any use of oral, intravenous, intra-articular, or intra-muscular corticosteroids within 1 month before the baseline MRI.\n- Pregnant or nursing (lactating) women.\n- Known recent drug or alcohol abuse.\n- Known severe psychiatric disease.\n- Incapable of complying with the examination program for physical or mental reasons.\n- Unable to speak, read, or understand Danish."}

Primary endpoints

• {"endpoint_text":"- Change from baseline to month 12 in total inflammatory burden in the entire body (peripheral and axial joints and entheses), as assessed by WB-MRI, in patients with axSpA and PsA treated with IXE","definition_or_measurement_approach":"Change from baseline to month 12 measured as total inflammatory burden in the entire body (peripheral and axial joints and entheses) assessed by whole-body MRI (WB-MRI)."}

Denmark

Earliest CTIS Part Ii Submission Date

02-04-2024

Latest Decision Or Authorization Date

05-04-2024

Processing Time Days

3

Number Of Sites

4

Number Of Participants

65

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}