E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-specific chronic low back pain of more than 6 months duration. We will only investigate those who have vertebral end-plate chanages(Modic changes) on MRI. |
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E.1.1.1 | Medical condition in easily understood language |
Low back pain for more than 6 months with no known cause, and oedema in end-plates of vertebra in the low back (seen on MRI scan) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008837 |
E.1.2 | Term | Chronic back pain |
E.1.2 | System Organ Class | 100000004859 |
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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 evaluate the effect of biosimilar infliximab on disease specific disability in patients with chronic low back pain and Modic Changes type 1 at 5 months |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of biosimilar infliximab on pain and bone marrow oedema, and to evaluate the cost-effectiveness and safety of biosimilar infliximab, in patients with chronic low back pain and Modic Changes type I at 5 months |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age between 18 and 65 years
-Low back pain of > 6 months duration with a Numerical Rating Scale (NRS) pain intensity score of 5
-Modic Changes type I in the lumbar vertebral body
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E.4 | Principal exclusion criteria |
-Any contraindication or increased risk of side-effects from Infliximab (such as ongoing infection, recent live vaccination or planned live vaccination, immunocompromised, ongoing glucocorticoid treatment or allergy against any products of the medication)
- Current pregnancy or lactation
- For women of childbearing potential; inadequate birth control, pregnancy, and/or breastfeeding.
- Not able to understand written and spoken Norwegian
- Not able to complete treatment or follow-ups in the study (i.e. contraindications for MRI, severe psychiatric disease, drug abuse or plans of moving) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Oswestry Disability Index (ODI) 2.0 ODI is a back pain-specific disability score frequently used in LBP research, especially recommended for the evaluation of treatment effects on patients recruited from secondary health care. It gives a summed up score from 0 (no disability) to 100 (maximum disability) based on 10 questions. A responder is defined as a patient reporting 30% improvement on ODI at main endpoint compared with baseline. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
ODI will be evaluated at 5 months after treatment start. ODI will be measured every month up to 5 months and at the Safety registration at 9 months.
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E.5.2 | Secondary end point(s) |
-Low back pain intensity - Mean of three Numeric Rating Scales (NRSs, range 0-10); current LBP, the worst LBP within the last 2 weeks, and usual/mean LBP within the last 2 weeks.
-Roland and Morris Disability Questionnaire (RMDQ) - RMDQ is a back pain specific measure of physical functioning, defined as an ability to carry out daily activities. The questionnaire consists of 24 questions with dichotomous answers regarding limitation of activities ‘today’, giving a sum score between 0 and 24.
- Health-related quality of life (the EQ-5D)
-MRI using Short tau inversion recovery (STIR) signal (intensity and extent) of MCs |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
LBP intensity and RMDQ will be measured every month up to 5 months and at the Safety registration at 9 months.
Health-related quality of life (the EQ-5D) will be evaluated at 5 months follow-up
Short tau inversion recovery (STIR) signal (intensity and extent) of MCs will be evaluated at baseline and 6 months |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Radiological, Genetics and Health economics |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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 | 6 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |