NCT03704363

BackToBasic: Infliximab in Chronic Low Back Pain and Modic Changes

Completed Phase 3 Last updated 8 March 2024

What this trial tests

Phase 3 trial testing Biosimilar Infliximab in Low Back Pain in 128 participants. Completed in 29 September 2023.

Timeline

12 December 2018

Primary endpoint
27 July 2023

29 September 2023

Quick facts

Lead sponsor	Oslo University Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	128
Start date	12 December 2018
Primary completion	27 July 2023
Estimated completion	29 September 2023
Sites	6 locations across Norway

Drugs / interventions tested

• Biosimilar Infliximab — full drug profile →
• Placebo

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

Oslo University Hospital

Who can join

Adults 18 to 65, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Low-Back Pain (LBP) is the leading cause of disability worldwide. Even though LBP relates to different underlying pathologies, there are a substantial number of patients with chronic complaints that have vertebral bone marrow lesions visualized as Modic changes (MC) on magnetic resonance imaging (MRI). Despite the clinical evidence that MC is painful, the etiology is unknown and there is currently no established treatment. It has been suggested that MCs are secondary to a biomechanically induced degradation with a subsequent autoimmune response, supported by evidence showing that Tumor necrosis factor (TNF)-α plays a critical role in intervertebral disc degeneration and MCs. Clinical trials suppressing inflammation with TNF-alfa blockers in patients with acute low back pain and sciatica provide evidence to support the initiation of a clinical trial assessing the effect of TNF-alfa blockers in patients with chronic low-back pain and MCs. Since TNF-alfa blockers is an established treatment for immune-mediated disorders like spondyloarthritis by reducing pain as well as bone marrow lesions, the researchers aim to assess whether this treatment is effective for chronic LBP with MCs. In addition refine diagnostic assessment and explore potential biomarkers, which will provide an increased understanding of underlying factors causing LBP, and ultimately result in better management and treatment for one of the most costly and challenging patient populations.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Painful intervertebral disc degeneration and inflammation: from laboratory evidence to clinical interventions.
   Lyu FJ, Cui H, Pan H, Mc Cheung K, et al · · 2021 · cited 352× · PMID 33514693 · DOI 10.1038/s41413-020-00125-x
2. Astrocytes in Chronic Pain: Cellular and Molecular Mechanisms.
   Lu HJ, Gao YJ. · · 2023 · cited 72× · PMID 36376699 · DOI 10.1007/s12264-022-00961-3
3. Should Degenerated Intervertebral Discs of Patients with Modic Type 1 Changes Be Treated with Mesenchymal Stem Cells?
   Herger N, Bermudez-Lekerika P, Farshad M, Albers CE, et al · · 2022 · cited 14× · PMID 35269863 · DOI 10.3390/ijms23052721
4. The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebo-controlled, multicenter trial.
   Gjefsen E, Bråten LCH, Goll GL, Wigemyr M, et al · · 2020 · cited 14× · PMID 33087100 · DOI 10.1186/s12891-020-03720-5
5. Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low-Back Pain With Modic Type 1 Changes: A Randomized Controlled Trial.
   Gjefsen E, Bråten LC, Ponzi E, Dagestad MH, et al · · 2025 · cited 6× · PMID 39624017 · DOI 10.1002/art.43073
6. Modic Change Edema in Chronic Low Back Pain Treated With Infliximab or Placebo: The BackToBasic Trial.
   Dagestad MH, Vetti N, Haugli Bråten LC, Gjefsen E, et al · · 2025 · cited 3× · PMID 40358067 · DOI 10.1097/brs.0000000000005391