Intravenous infusion(biosimilar infliximab). Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98, unless unacceptable toxicity is encountered.

Intravenous infusion (NaCl intravenous infusion). Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98.

Low Back Pain

Intravenous infusion(5 mg/kg). Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98, unless unacceptable toxicity is encountered.

Biosimilar Infliximab

Intravenous infusion. Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98,

Placebo

Haukeland University Hospital

Vestre Viken Hospital Trust Drammen

Østfold Hospital Trust

Oslo University Hospital Ullevål

University Hospital of North Norway

St. Olavs Hospital

BackToBasic: Infliximab in Chronic Low Back Pain and Modic Changes

The Effect of Infliximab in Patients With Chronic Low Back Pain and Modic Changes. A Randomized, Double Blind, Placebo-controlled, Multicenter Trial

ODI is a disease-specific disability score. Scale is measured 0-100, better to worse respectively.

Based on Magnetic Resonance Imaging (MRI). STIR result from evaluations of fat-water separation and T1 weighted fat-saturated post-contrast images, MC signal intensity standardized against the intensity of normal vertebral body marrow and cerebrospinal fluid, MC high signal craniocaudal size and volume.

Measured on a Numeric Rating Scale (NRS: 0-10); mean of three NRS scales; current LBP, the worst LBP within the last 2 weeks, and usual/mean LBP within the last 2 weeks (at baseline, post-treatment and at one year after start of treatment). Will also be monitored weekly during the intervention period, and the the wording "last 2 weeks" will then be replaced by "the last week". Better (0) to worse (10) respectively.

RMDQ is a Self-reported disease-specific disability score, scale 0-24, better to worse respectively.

EuroQoL-5D-5L (version 2.0), range -0.59 to 1.0, worse to better respectively.

Will be reported by patients monthly during the study period for health-economical calculations

Self-reported by patients; how many days patients were on sick-leave last month (if patients are sick listed; degree / % sick listed will also be registered).

Adverse events frequency. The nature of the event(s) will be described by the investigator in precise standard medical terminology, duration and intensity will also be registered.

Numeric Rating Scale (NRS: 0-10, better to worse respectively); leg pain last week.

Number of days during the last 28 days (4 weeks) the participant had experienced LBP (0-28 days), and, on an typical day, how many of the hours awake they experienced LBP (0-16 h). The number of days and hours are multiplied (a 0-448 scale).

Measured on a 5-point Likert scale with 'very satisfied', 'some satisfied', 'neither satisfied nor dissatisfied', 'some dissatisfied' or 'very dissatisfied'

Rated on a 5-point Likert scale; patients rate satisfaction with treatment

Global Rating of Change is rated on a 7-point Likert scale to quantify a patient's self-judged improvement from baseline.

Patients will be asked about which study medicine (Infliximab / placebo / unsure) they think they received during the intervention period of the study.

Kjersti Storheim

Oslo University Hospital

Vestre Viken Hospital Trust

Clinical Trial Unit (CTU), Oslo University Hospital

Diakonhjemmet Hospital

A computer-generated randomised allocation sequence will be imported into an electronic case report form (eCRF) system (Viedoc) and made available exclusively to a study nurse (mixing nurse) authorised by the local principal investigator to prepare infusions. The mixing nurse is otherwise not involved in the treatment of the patient. The infusion bags containing the study medication will be prepared by the mixing nurse in identical infusion bags, and applied labels with patient number and dose such that blinding of the participants is secured. The Investigational Medicinal Products (IMPs) have the same color and will look the same. After preparing the IMP, the mixing nurse will hand over the IMP to another nurse, blinded to allocation, and authorised by the local principal investigator to administer the infusion.

adalimumab (2 subcutaneous 40 mg injections on day 0 and 7)

Sciatica

Adalimumab

Placebos

Geneva University Hospital

Adalimumab in Severe and Acute Sciatica

Evolution of leg pain over time. Pain will be assessed using a Visual Analog Scale (VAS).

Percentage of amelioration for VAS and ODI (Oswestry Disability Index)

Assessment of patient's statisfaction and expectations using the SF12 general health questionnaire.

Percentage of amelioration for ODI (Oswestry Disability Index)

sciatica/necrosis

BackToBasic: Infliximab in Chronic Low Back Pain and Modic Changes

Adalimumab in Severe and Acute Sciatica

Lumbar Spinal Fibrosis and TNF Alpha Inhibition

Efficacy of Epidural Etanercept in the Treatment of Sciatica

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