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. MedDRA version: 20.0 Level: LLT Classification code 10008837 Term: Chronic back pain System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Zessly 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Product Name: Infliximab
Pharmaceutical Form: Powder and solvent for solution for infusion
Pharmaceutical form of the pla
Sponsors
FOU, Nevroklinikken, Oslo University Hospital -Ullevål
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 126 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;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. ;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;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 | — |
Countries
Norway
Contacts
Public ContactJohn-Anker Zwart
FORMI (Formidlingsenheten for muskel- og skjelettlidelser, Oslo University Hospital -Ullevål
Outcome results
None listed