E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Low back pain with and without legg-pain
In the late periode 1990ies it became clear that various cytokines and other inflammatory elements played a large role for low back pain. One of the known inflammatory substances TNF-α (Tumor Necrosis Factor-α) has been demonstrated in the discs’ nuclear tissue, particular with degeneration. |
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E.1.1.1 | Medical condition in easily understood language |
Low back pain
In the late periode 1990ies it became clear that inflammation played a large role for low back pain. TNF-α treatment may be usefull. |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024891 |
E.1.2 | Term | Low back pain |
E.1.2 | System Organ Class | 100000004859 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024892 |
E.1.2 | Term | Low back pain (without radiation) |
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 |
In this observational pilot trial, where we aim at studying the possible feasibility of TNF-α inhibitor treatment against chronic discugen Low back pain. |
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E.2.2 | Secondary objectives of the trial |
In this observational pilot trial, where we aim at studying inflammatory blood markers presence in these LBP cases, and their optional reduction with Humira treatment. Further, the presence and location of optional inflammation following what is deemed to be included in long-lasting, discogenic LBP, using Dynamic Enhanced Contrast (DEC-)MRI. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients between 18-65 years
Operation (spondylodesis) is considered
A current episode of 3-12 months of low back pain without clinical indications of soon recovery. Back pain [>40 / VAS scale 0 (no pain) – 100 (maximum imaginable pain)] dominates over possible leg pain.
A conventional MRI no older than 4 weeks are speaking for discogenic LBP
A degenerative disc (> Pfirrmann grade 3), corresponds location wise to the maximum site of pain.
Modic change type 1 in previous conventional MRI scan
The level of the deemed discogenic LBP must correspond by a physician’s ‘springing test’ (a.m. McKenzie) over the same lumbar level, as this will speak for a single level affection.
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E.4 | Principal exclusion criteria |
Women with pregnancy potential have to undergo a pregnancy test prior to injection and scannings. Contraceptives is mandatory up to 3 months after treatment given. Further, planned pregnancy within the first 3 months after treatment cannot participate. Hereby, following the guidelines by Danish Health and Medicines Authority (Sundhedstyrelsen) See 8.2.
Active or latent tuberculosis
Hepatitis B and C infection
Diabetes
Planning surgery in the spine not related to the discugenic pain.
Invasive cancer disease
Spondylartropaty, Rheumatoid arthritis or other inflammatory joint disease
Severe heart disease or failure
Prior spine infection
COPD - Chronic obstructive airway disease
Surgery in the lumbar spine
Any previous treatment with Etanercept
Allergy to Humira
Allergy to Gadolinium contrast
Decreased estimated glomerular filtration rate (eGFR <60 ml/min/1.73m2) assessed by blood test
Widespread pain (clear non-organic symptoms)
Patients with inability to communicate in Danish or in English
“Red flag symptoms.”
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E.5 End points |
E.5.1 | Primary end point(s) |
1 Pain will be evaluated by using the 13 items Pain-Detect questionnaire, which includes measurements of LBP on an ordinal 11-point numerical rating scale (NRS: 0 = no LBP; 10 = worst possible LBP)
2 The validated 24-item Oswestry Disability Index will measure participant-rated LBP disability
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Will be evaluated 3, 6 and 12 months post-baseline |
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E.5.2 | Secondary end point(s) |
1 Dynamic Contrast Enhanced -MRI
2. Inflammations markers hsCRP, IL-1, TNF-alfa |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Will be evaluated 3, 6 and 12 months post-baseline |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
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 | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | 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
| 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 | Yes |
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 study will stop inclusion when 40 persons have received treatment or placebo. Sponsor may at any time stop the project. The project will be stopped if any circumstances compromise the safety of trial participants or pose a health risk. When suspected, the project will initially be suspended while the relationship explored, and can be determined whether the relationship can be attributed to the intervention and / or the studie’s assessments.
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |