INFLIXIMAB for Axial spondyloarthritis

Inclusion criteria

• {"criterion_text":"- A written informed consent form approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) has been signed by the patients.\n- Patients must not have received pre -treatment b- and ts-DMARDs prior to the baseline visit ('bDMARD naïve').\n- Female patients of childbearing potential (FCBP) must use an effective method of contraception (including oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier, and spermicide or contraceptive methods considered at least as safe for contraception). FCBP must agree to use effective contraception during the study and for at least 6 months (according to the Summary of Product Characteristics) after the last dose of study treatment.\n- Male subjects who are not documented to be sterile must agree to ensure that they or their partner(s) use adequate contraception for the duration of the study.\n- Patients are at least 18 years of age at the time of the baseline visit.\n- Patients are considered reliable and are able to adhere to the protocol, comply with the schedule of visits, or take medications as judged by the investigator.\n- Diagnosis of r-axSpA by a rheumatologist.\n- Fulfilment of the ASAS classification criteria.\n- High disease activity status (ASDAS ≥2.1).\n- Positive MRI examination with inflammatory activity in the sacroiliac joint and/or the spine.\n- Patients must agree to the planned MRI procedures.\n- Patients must have failed NSAID therapy in outpatient care."}

Exclusion criteria

• {"criterion_text":"- Patients have participated within the past 3 months or are currently participating in another study with an investigational drug (or medical device).\n- Patients who are unable to speak and read German .\n- Patients have a history of chronic alcohol or drug abuse.\n- Patients have a medical or psychiatric condition that, in the opinion of the investigator, would jeopardize or impair the ability to participate in this study.\n- Contraindication to TNF blocker or NSAID therapy.\n- Patients have a known hypersensitivity to any component of Remsima or the NSAIDs used in the study.\n- Pre-treatment with a b- or ts-DMARD.\n- Patients must not have any other inflammatory arthritis, e.g., RA, systemic lupus erythematosus, sarcoidosis, or others.\n- Patients must not have a secondary, non -inflammatory condition (e.g., osteoarthritis or fibromyalgia) that, in the opinion of the investigator, is sufficiently prominent to interfere with the evaluation of the effect of study drug on the primary diagnosis of axial SpA.\n- Female patients who are breastfeeding, pregnant, or plan to become pregnant during the study.\n- Patients who have received a live vaccination within the last 8 weeks prior to baseline.\n- Current malignancy or history of malignancy, although patients with less than 3 completely excised basal cell carcinomas or with one successfully operated cervical carcinoma in situ more than 5 years prior to baseline may be included.\n- Patients with severe, progressive, and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, or neurologic disease or with a history of such disease.\n- Patients with any other condition, including the presence of laboratory abnormalities, which, in the judgment of the investigator, makes the subject unsuitable for participation in the study.\n- Patients with any contraindication to perform MRI or failure to perform MRI prior to baseline.\n- Patients with clinically important active infections.\n- Female patients with positive urine pregnancy test.\n- Positive interferon gamma release assay (IGRA) test at screening and/or abnormal chest x -ray (within 3 months prior to baseline) suggestive for past or present tuberculosis.\n- Chronic infection such as hepatitis B or C infection.\n- Immunocompromised patients or history of HIV infection.\n- Patients who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g., family members).\n- Have participated in this study before"}

Primary endpoints

• {"endpoint_text":"- Comparison of the proportion of patients on NSAID vs TNF blocker treatment who have low disease activity (ASDAS <2.1) after 12 weeks of treatment.","definition_or_measurement_approach":"Proportion of patients achieving ASDAS <2.1 (low disease activity) at 12 weeks; measurement by ASDAS instrument at week 12."}

Secondary endpoints

• {"endpoint_text":"- Comparison of the proportion of patients on NSAID vs TNF blocker treatment who have low disease activity (ASDAS <2.1) after 4 and 24 weeks of treatment.","definition_or_measurement_approach":"Proportion of patients achieving ASDAS <2.1 assessed at weeks 4 and 24."}
• {"endpoint_text":"- ASDAS-ID (inactive disease, ASDAS < 1.3), ASDAS -CII (clinically important improvement, Δ ≥ 1.1), ASDAS -MI (major improvement, Δ ≥ 2.0) after 4, 12 and 24 weeks.","definition_or_measurement_approach":"ASDAS thresholds: inactive disease ASDAS <1.3; CII Δ ≥1.1; MI Δ ≥2.0 assessed at weeks 4, 12, 24."}
• {"endpoint_text":"- ASAS-20, ASAS-40 at 4, 12 and 24 weeks.","definition_or_measurement_approach":"ASAS response criteria (20% and 40% improvement) assessed at weeks 4, 12, 24."}
• {"endpoint_text":"- BASDAI50 at weeks 4, 12 and 24 .","definition_or_measurement_approach":"Proportion achieving BASDAI50 (50% improvement) at weeks 4, 12, 24."}
• {"endpoint_text":"- Change from baseline in Total Back Pain (PtBP), Patient Global Assessment (PtGA). Physician Global Assessment (PhGA) and other measures of disease activity (BASDAI), function (BASFI) at week 2, 4, 6, 12, 24, mobility (BASMI) and quality of life (ASAS Health Index) at week 4, 12, 24 .","definition_or_measurement_approach":"Change from baseline in listed patient- and physician-reported measures at specified timepoints (weeks 2,4,6,12,24 as stated)."}
• {"endpoint_text":"- Change from baseline in inflammatory activity in the MRI scan used for diagnosis at escalation and after 24 weeks.","definition_or_measurement_approach":"Change from baseline in MRI inflammatory activity used for diagnosis, assessed at escalation and at 24 weeks."}
• {"endpoint_text":"- Change from baseline in Epionics spine dimensions after 24 weeks .","definition_or_measurement_approach":"Change from baseline in Epionics spine measurements at 24 weeks."}
• {"endpoint_text":"- Normalized net incremental area under the curve for ASDAS, Total Back Pain (PtBP), Patient Global Assessment (PtGA). Physician Global Assessment (PhGA) and other measures of disease activity (BASDAI), function (BASFI), mobility (BASMI, Epionics spine) and quality of life (ASAS Health Index).","definition_or_measurement_approach":"Normalized net incremental AUC over study period for listed outcome measures."}
• {"endpoint_text":"- Time to achieve ASDAS-LDA and time to ASDAS-ID.","definition_or_measurement_approach":"Time-to-event analyses measuring time until achievement of ASDAS low disease activity (LDA) and ASDAS inactive disease (ID)."}
• {"endpoint_text":"- Change from baseline in the laboratory examination (CRP) over the time of he examination period.","definition_or_measurement_approach":"Change from baseline in CRP values over the examination period."}
• {"endpoint_text":"- Comparison of the proportion of patients who discontinue therapy due to intolerance or side effects.","definition_or_measurement_approach":"Proportion of patients discontinuing therapy for intolerance/side effects compared between arms."}
• {"endpoint_text":"- Incidence of adverse events and treatment emergent AEs and SAEs.","definition_or_measurement_approach":"Incidence rates of AEs, treatment-emergent AEs, and SAEs collected during study."}

Germany

Earliest CTIS Part Ii Submission Date

06-11-2024

Latest Decision Or Authorization Date

06-09-2025

Processing Time Days

304

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"ALGORA Gesellschaft fuer Medizinstatistik und Vertriebssysteme mbH","duties_or_roles":"sponsorDuties codes: 1,10,11,6,8","organisation_type":"Pharmaceutical company"}
• {"country":"","full_name":"Celltrion Healthcare Deutschland GmbH","duties_or_roles":"Source of monetary support","organisation_type":""}