GOLIMUMAB for Peripheral spondyloarthritis

Inclusion criteria

• {"criterion_text":"- Subjects must be between 18 and 65 years of age.\n- Subjects must have been diagnosed with peripheral spondyloarthritis by the treating rheumatologist.\n- Subjects must meet the ASAS classification criteria for peripheral spondyloarthritis: subjects must have current arthritis (asymmetric or predominantly in the lower limbs) or current enthesitis (except for enthesitis only along the spine, sacroiliac joints and/or chest wall) or current dactylitis plus at least 1 SpA features\n- Subjects must have had onset of peripheral SpA symptoms ≤12 months prior to the screening visit.\n- Subjects must have active disease at screening defined by Patient Global Assessment of Disease Activity Numerical Rating Scale (NRS) ≥ 4 and Patient Global Assessment of Pain NRS ≥ 4. At the baseline visit patients will be clinically evaluated to exclude spontaneous clinical remission.\n- In subjects with concurrent axial SpA symptoms, the peripheral SpA symptoms must be the predominant symptoms at study entry based on the Investigator's clinical judgment."}

Exclusion criteria

• {"criterion_text":"- Medical history of inflammatory arthritis of a different etiology than peripheral spondyloarthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout, …).\n- History of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.\n- Have received any live virus or bacterial vaccination within 3 months prior to the first administration of study agent; patients who are expected to receive such vaccinations during the trial, or within 3 months after the last administration of study agent.\n- Positive serum pregnancy test at screening.\n- Female subjects who are breast-feeding.\n- Clinically significant abnormal screening laboratory results as evaluated by the Investigator.\n- Positive anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of normal.\n- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.\n- Subject with current symptoms of fibromyalgia that would confound evaluation of the patient.\n- Prior adequate treatment with methotrexate and/or sulphasalazin\n- Prior exposure to any biologic therapy with a potential therapeutic impact on SpA.\n- Treatment with any investigational drug of chemical or biological nature within a minimum of 30 days or 5 half-lives of the drug (whichever is longer) prior to the Baseline Visit.\n- Infection(s) requiring treatment with intravenous (iv) anti-infective agents within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the baseline Visit.\n- Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.\n- History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease.\n- History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB.\n- (History of) chronic heart failure, including medically controlled, asymptomatic CHF."}

Primary endpoints

• {"endpoint_text":"- Proportion of patients achieving clinical remission.","definition_or_measurement_approach":"Not specified in the available data."}

Secondary endpoints

• {"endpoint_text":"- Comparison between the \"TNFi induction\" group and the \"csDMARD Step-up\" group regarding:Achievement of \"sustained clinical remission\" at week 24 (and week 36 for the patients remaining on blinded study medication).","definition_or_measurement_approach":"Sustained clinical remission assessed at specified timepoints (week 24 and week 36 for some patients) as stated; exact remission definition not provided in available data."}
• {"endpoint_text":"- Comparison between the \"TNFi induction\" group and the \"csDMARD Step-up\" group regarding:Improvement from baseline to week 12 and 24 in individual clinical assessments (78-Tender Joint Count, 76-Swollen Joint Count, Dactylitis Count, SPARCC Enthesitis Score) and composite scores (ASDAS: Axial Spondyloarthritis Disease Activity Score).","definition_or_measurement_approach":"Measured by change from baseline to week 12 and 24 in specified joint counts, dactylitis count, SPARCC Enthesitis Score and ASDAS composite score."}
• {"endpoint_text":"- Comparison between the \"TNFi induction\" group and the \"csDMARD Step-up\" group regarding:Improvement from baseline to week 12 and 24 in patient-reported outcomes (Patient global assessment of disease activity and pain, BASDAI, BASFI, ASAS Health Index.","definition_or_measurement_approach":"Patient-reported outcome instruments (Patient global assessment of disease activity and pain, BASDAI, BASFI, ASAS Health Index) assessed at baseline, week 12 and week 24."}
• {"endpoint_text":"- Comparison between the \"TNFi induction\" group and the \"csDMARD Step-up\" group regarding:Improvement from baseline to week 12 and 24 in inflammatory parameters (ESR, CRP).","definition_or_measurement_approach":"Laboratory inflammatory markers ESR and CRP measured and compared from baseline to week 12 and 24."}
• {"endpoint_text":"- Comparison between the \"TNFi induction\" group and the \"csDMARD Step-up\" group regarding:Changes in concomitant NSAID intake (NSAID-index) and \"escape\" intra-articular glucocorticoid injections between baseline and week 24.","definition_or_measurement_approach":"Changes in NSAID-index and counts of intra-articular glucocorticoid injections between baseline and week 24."}
• {"endpoint_text":"- Difference in occurrence of (serious) adverse events (AEs) and AEs of specific interest between the 2 treatment strategies from baseline to week 24 (and week 36 for patients remaining on blinded study medication). Descriptive analysis of the number and type of adverse events between both strategies","definition_or_measurement_approach":"Safety assessed by recording (serious) AEs and AEs of specific interest from baseline to week 24 (and week 36 where applicable); descriptive analysis of number and type of events."}
• {"endpoint_text":"- Percentage of patients achieving (sustained) clinical remission with open-label golimumab treatment after failure of the initial randomized, blinded treatment strategy. Exploration of difference in percentage of patients that reach (sustained) clinical remission according to symptom duration (<3 months versus ≥3 month and <12 months).","definition_or_measurement_approach":"Percentage achieving sustained clinical remission after open-label golimumab; subgroup exploration by symptom duration (<3 months vs ≥3 and <12 months). Exact remission definition not provided."}

Belgium

Earliest CTIS Part Ii Submission Date

05-12-2023

Latest Decision Or Authorization Date

24-04-2025

Processing Time Days

506

Number Of Sites

6

Number Of Participants

150

Primary sponsor

Full Name

Universitair Ziekenhuis Gent

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"MSD Belgium","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"VIB","duties_or_roles":"Monetary support","organisation_type":""}