E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
early axial spondyloarthritis (axSpA) in relation to gut inflammation |
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E.1.1.1 | Medical condition in easily understood language |
early axial spondyloarthritis (axSpA) in relation to gut inflammation |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To describe and confirm the relationship between subclinical gut inflammation and axSpA. - To evaluate whether there is a higher need of anti-tumor necrosis factor α (anti-TNFα) treatment in axSpA patients with (subclinical) gut inflammation compared to those without. |
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E.2.2 | Secondary objectives of the trial |
- To describe the clinical response of a treat-to-target principle in early axSpA and explore the possibility of drug-free remission. - To evaluate the relation between the presence of (subclinical) gut inflammation and the therapeutic response to anti-TNFα in patients with axSpA. - To evaluate the relationship between (subclinical) gut inflammation on the one hand and remission induction and relapse on the other hand in patients with axSpA. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subject must have a diagnosis of axSpA and classified according to ASAS criteria. - Subject is between 18 and 46 years at the screening visit. - Subject has at least 3 months and maximum 1 year (almost) daily chronic back pain. - Subject has an active disease defined as a positive MRI (according to ASAS definition) or elevated CRP (in patients who are HLA-B27+) and an ASDAS score > 2.1 (at least high disease activity). |
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E.4 | Principal exclusion criteria |
- Full anti-inflammatory dose of NSAIDs for more than 4 weeks for the duration of the axSpA symptoms. - Prior exposure to any biologic therapy with a potential therapeutic impact on SpA, including anti-TNF therapy. - Exposure to disease-modifying drugs (DMARDSs; i.e. methotrexate and sulfasalazine) in the last 3 months before the ileocolonoscopy. - Exposure to systemic corticosteroid treatment in the last 14 days before the ileocolonoscopy. - Infection(s) requiring treatment with intravenous antibiotics/antivirals/antifungals within 30 days prior to the baseline visit or oral antibiotics/antivirals/antifungals 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 of active hepatitis B infection, hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis. - Have a history of, or concurrent, chronic heart failure, including medically controlled, asymptomatic congestive heart failure. - Evidence of dysplasia or 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, or are expected to receive, any live virus or bacterial vaccination within 3 months prior to the first administration of study agent, during the trial, or within 6 months after the last administration of study agent. - Positive pregnancy test at screening - Female subjects who are breast-feeding or considering becoming pregnant during the study. - Female subjects who do not use contraceptives. - History of clinically significant drug or alcohol abuse in the last 12 months. - Clinically significant abnormal screening laboratory results as evaluated by the investigator. - Positive rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of the normal. - Subject with diagnosis and current symptoms of fibromyalgia. - Any medical or psychological condition that, in the opinion of the investigator, could jeopardize or compromise the subject’s ability to participate in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
evaluated on 2 consecutive follow-up visits (interval: 12 weeks) |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
evaluated by ileocolonoscopy at time of clinical remission |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |