peripheral spondyloarthritis MedDRA version: 20.0 Level: PT Classification code 10051265 Term: Spondyloarthropathy System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Ledertrexate
Pharmaceutical Form: Capsule
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects must be between 18 and 65 years of age. - Subjects must have been diagnosed with peripheral spondyloarthritis by the treating rheumatologist. - 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 - Subjects must have had onset of peripheral SpA symptoms =12 months prior to the screening visit. - 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. - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: • Medical history of inflammatory arthritis of a different etiology than peripheral spondyloarthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout, …). • Prior adequate treatment with methotrexate and/or sulphasalazine. • Prior exposure to any biologic therapy with a potential therapeutic impact on SpA. • 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. • 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. • Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab. • History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease. • 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. • (History of) chronic heart failure, including medically controlled, asymptomatic CHF. • 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. • 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. • Positive serum pregnancy test at screening. • Female subjects who are breast-feeding. • Clinically significant abnormal screening laboratory results as evaluated by the Investigator. • Positive anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of normal. • Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study. • Subject with current symptoms of fibromyalgia that would confound evaluation of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare a standard step-up approach using conventional synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs), such as methotrexate and/or sulphasalazine (the “csDMARD Step-Up”-strategy), with an early remission-induction treatment strategy that immediately introduces biological DMARDs (bDMARDs) as the first step in the treatment algorithm; in this group the Tumor Necrosis Factor inhibitor (TNFi) golimumab will be utilised (the “TNFi Induction”-strategy).;Secondary Objective: To define the window of opportunity within which temporary treatment with bDMARDs might be more effective, by stratifying patients according to symptom duration: patients with shorter symptom duration (<3 months) versus those with more longstanding disease (between 3-12 months of symptom duration).;Primary end point(s): proportion of patients achieving clinical remission;Timepoint(s) of evaluation of this end point: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: week 12, 24, 36, 48, 60;Secondary end point(s): - Comparison between the “TNFi induction” group and the “csDMARD Step-up” group regarding: o Achievement of “sustained clinical remission” at week 24 (and week 36 for the patients remaining on blinded study medication). o 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). o 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. o Improvement from baseline to week 12 and 24 in inflammatory parameters (ESR, CRP). o Changes in concomitant NSAID intake (NSAID-index) and “escape” intra-articular glucocorticoid injections between baseline and week 24 - 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 - Percentage of patients achieving (sustained) clinical remission with open-label golimumab treatment after failure of the initial randomized, blinded treatment strategy. o Exploration of difference in percentage of patients that reach (sustained) clinical remission according to symptom duration (<3 months versus =3 month and <12 months). - For patients in SPARTACUS Phase B (drug-free remission period): o Exploration of the duration of drug-free remission. o Time to (documented) pSpA disease flare. o Time to restart of “standard-of-care” pSpA treatment. o Exploration of clinical parameters that could be predictive for reaching (sustained) clinical remission and/or flare. - Correlation between the “Patient Acceptable Signs & Symptoms Imp | — |
Countries
Belgium
Contacts
Public ContactHIRUZ
Ghent University Hospital
Outcome results
None listed