E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10071400 |
E.1.2 | Term | Axial spondyloarthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 compare a treat-to-target (T2T) intense treatment approach with a routine treatment approach (Standard of Care [SOC]) in reducing disease activity at week 32 in patients with axial spondyloarthritis (axSpA). |
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E.2.2 | Secondary objectives of the trial |
To compare a T2T intense treatment approach with SOC by assessing the following: improvement of quality of life, improvement of function, improvement of work productivity, reducing inflammation, reducing disease activity |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Diagnosis of axial SpA (either ankylosing spondylitis or non-radiographic axial SpA) and fulfilling the ASAS classification criteria for axial SpA
2. Subjects aged ≥ 18 years
3. Disease duration < 5 years
4. Subjects must have a baseline disease activity as defined by having an ASDAS ≥ 2.1 or a BASDAI ≥ 4
5. Subjects must be either NSAID-naïve or had not been treated with the maximal recommended dose during the last 2 weeks prior to the Baseline Visit. |
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E.4 | Principal exclusion criteria |
1. Contraindications for NSAIDs or Tumor Necrosis Factor (TNF) blocker according to local labeling
2. If entering the study on concomitant NSAIDs, subjects taking the maximal recommended dose during the 2 weeks prior to Baseline or have failed or developed intolerance to a NSAID taken at maximal recommended dose for 2 weeks or more at any time
3. Prior exposure to any anti-TNF therapy; any biologic therapy with a potential therapeutic impact on SpA, or subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline Visit. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical disease activity at Week 32 as measured by the percentage of subjects with ASDAS inactive disease (ASDAS < 1.3) in the two treatment arms. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Quality of life: EQ-5D Questionnaire, Work Productivity and Activity Impairment: WPAI-axSpA, Overall functioning: ASAS HI, Disease activity: BASDAI, Percentage of subjects achieving 50% improvement in BASDAI, Function: BASFI NRS score, Disease activity: ASDAS, Percentage of subjects in ASDAS inactive disease (ASDAS < 1.3), Percentage of subjects with low disease activity (ASDAS < 2.1), Percentage of subjects with moderate disease activity (ASDAS ≥1.3 to < 2.1), Percentage of subjects with high disease activity (ASDAS ≥ 2.1 to < 3.5), Percentage of subjects with very high disease activity (ASDAS ≤ 3.5), ASAS 20, ASAS 40, and ASAS Partial Remission, Active inflammation: MRI of the sacroiliac joints and the spine, Physician’s Global Assessment of Disease Activity, Patient’s Global Assessment of Disease Activity, Patient’s Global Assessment of Pain, Swollen Joint Count, Tender Joint Count, Change from baseline in MASES, Change from baseline in Dactylitis count, Anterior uveitis, C-reactive Protein, Erythrocyte sedimentation rate, ASDAS course over time, BASDAI course over time. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 30 |
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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The end of study is defined as the date of the last subject last visit or the last follow-up contact, whichever is longer. |
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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 | |
E.8.9.1 | In the Member State concerned days | |