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Low Back PainPhase 3NCT03704363

BackToBasic: Infliximab in Chronic Low Back Pain and Modic Changes

A Phase 3 study testing Biosimilar Infliximab in people with Low Back Pain, run by Oslo University Hospital at 6 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain
What is being tested?
Biosimilar Infliximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
6 sitesNorway
Study dates
12 Dec 2018to 29 Sep 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 65 years
  • LBP of > 50% of days for > 6 months duration in the area below the 12th rib and above the gluteal folds with:
  • Numerical Rating Scale (NRS) pain intensity score of at least 5 (mean of three NRS scales; current LBP, the worst LBP within the last 2 weeks, and usual/mean LBP within the last 2 weeks) and/or ODI-score of at least 25
  • Modic change of craniocaudal size >= 10% of vertebral height and of primary or secondary type 1 in the vertebral body at a level of the lumbar spine (superior or inferior endplate, Th12-S1).

Who cannot join

  • Fever or ongoing infection
  • Allergy or hypersensitivity against any products of the medication
  • Previous infliximab treatment
  • Any serious adverse events with other immunosuppressive treatment (including cytostatics, antibodies, drugs acting on immunophilins, Interferons, mycophenolate and any other DMARDs)
  • Any specific diagnosis that may explain patient's low back symptoms (e.g. tumor, fracture, spondyloarthritis, infection, spinal stenosis).
  • Former low back surgery (L1 - S1) for other reasons than disc herniation or decompression (e.g fusion, disc prosthesis).
Show all 31Show fewer
  • Former surgery for disc herniation or decompression within the last 12 months
  • Any known rheumatic disease
  • Current pregnancy or lactation
  • For women of childbearing potential (WOCBP); inadequate birth control, pregnancy, and/or breastfeeding. WOCBP is defined as those who are fertile (with uterus, fallopian tubes and at least one intact functional ovary), following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Documentation of surgical procedure or physical examination is required for subjects who have had such an operation. Adequate contraception must be used by WOCBP during the entire intervention period and 6 months after the last administration of study drug, and includes oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or system, vasectomized partner or sexual abstinence.
  • Ongoing systemic glucocorticoid or other immunosuppressive treatments (see list above)
  • Regular use of opioids with the exception of codeine and tramadol
  • Other immunosuppressive treatment last year (see list above)
  • Active or latent (known or suspected) tuberculosis (all participants will be screened for latent tuberculosis)
  • Previous infection with Hepatitis B virus (HBV) (all participants will be screened for HBV-carrier state)
  • Live vaccination within the last 4 weeks or planned live vaccination during treatment period
  • Planned surgical procedure
  • Increased transaminases (ASAT/ALAT)
  • Ongoing or previous malignant disease at any time (i.e. skin cancer, cervical cancer etc.)
  • Known increased risk of malignant disease
  • Diabetes
  • Immunodeficiency (I.e primary immunodeficiency diseases, human immunodeficiency virus/acquired immunodeficiency syndrome, splenectomy)
  • Heart failure (NYHA class III - IV)
  • Previous or ongoing psoriasis
  • Ulcerative colitis or Crohns disease
  • Existing or recent demyelination diseases (I.e. MS or Guillain-Barres)
  • Abnormal hemoglobin or abnormal platelet, leucocyte or neutrophil count
  • Not able to understand written and spoken Norwegian
  • Not able to complete treatment or follow-ups in the study (i.e. severe psychiatric disease, drug abuse or plans of moving address)
  • Contraindications for MRI (ie. pacemaker, metal implants, claustrophobia)
  • Abnormal creatinine level

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Norway6 sites

  • Haukeland University Hospital

    Bergen

  • Vestre Viken Hospital Trust Drammen

    Drammen

  • Østfold Hospital Trust

    Moss

  • Oslo University Hospital Ullevål

    Oslo, 0407

  • University Hospital of North Norway

    Tromsø

  • St. Olavs Hospital

    Trondheim

Other trials in Norway

About this study

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

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.

Read the detailed description

The following information will be collected at baseline, in addition to pre-specified efficacy assessments: age, gender, BMI (measured at site), ethnicity, marital status, children, educational level, work status, physical work load, leisure time activity, smoking habits, expectations about treatment effect and characteristics of pain (duration, agrevating factors, morning stiffness, morning pain, relief by NSAIDs, night time pain and former treatment). Emotional distress will be measured using the Hopkins Symptom Checklist-25 at baseline. The researchers will measure fear-avoidance beliefs about physical activity and work with Fear-avoidance beliefs Questionnaire (FABQ) at baseline. Subjective health complaints (SHC) will be measured using a formal inventory which consists of 29 questions concerning severity and duration of subjective somatic and psychological complaints and will be measured at baseline. In addition, routine clinical investigations (pain provocation tests (springing test, active flexion / extension of the lumbar spine) and neurological tests (strength, toe-/heel walking, sensibility, reflexes, straight leg raising test, reverse Lasegue test)) will be structured and registered in the CRF at baseline.

Conditions
Low Back Pain
Being tested
Biosimilar Infliximab, Placebo
Keywords
Modic changes, biomarkers, treatment, infliximab, chronic low back pain
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biosimilar InfliximabDrug

    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.

  • PlaceboOther

    Also called NaCl intravenous infusion

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

Study groups in NCT03704363
Study groupRoleWhat they receive
InfliximabExperimentalIntravenous 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.
Receives: Drug: Biosimilar Infliximab
PlaceboPlacebo comparatorIntravenous infusion (NaCl intravenous infusion). Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Oswestry Disability Index (ODI) from baseline to 5 months

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

    Measured: 0, 1, 2, 3, 4, 5 and 9 months

Secondary outcomes (7)

  1. Change in Short tau inversion recovery (STIR) signal (intensity and extent) of Modic Changes from baseline to 5 months.

    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: 0 and 5-6 months

  2. Change in low back pain intensity from baseline to 5 months

    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.

    Measured: 0 + weekly during intervention period, 3, 5 and 9 months

  3. Change in Roland Morris Disability Questionnaire (RMDQ) from baseline to 5 months

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

    Measured: 0, 3, 5 and 9 months

  4. Change in Health-related quality of life from baseline to 5 months

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

    Measured: 0, 3, 5 and 9 months

  5. Number and type of co-interventions (other pharmacological treatment (ATC-coded) and non-pharmacological treatment)

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

    Measured: Will be registered every month up to 5 months and at 9 months

  6. Days with sick leave

    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).

    Measured: Will be registered at baseline and monthly until last follow-up

  7. Incidence of adverse events (AEs) and serious AE (SAEs) during the study period

    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. In the evaluation, we will also consider serum infliximab concentration and vital signs.

    Measured: 2, 6, 14, 22 and 40 weeks after start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2018
  2. Study start12 Dec 2018
  3. Primary completion27 Jul 2023
  4. Study completion29 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03704363
Sponsor's protocol ID
2017/2450
Status last verified
Mar 2024
First submitted
19 Sep 2018
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gjefsen E, Braten LC, Ponzi E, Dagestad MH, Marchand GH, Kadar T, Bakland G, Haugen AJ, Granviken F, Florenes TW, Vetti N, Grovle L, Nilsen AT, Lunestad A, Holmgard TE, Valberg M, Bolstad N, Espeland A, Brox JI, Goll GL, Storheim K, Zwart JA. Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low-Back Pain With Modic Type 1 Changes: A Randomized Controlled Trial. Arthritis Rheumatol. 2025 May;77(5):615-623. doi: 10.1002/art.43073. Epub 2025 Jan 15.

    PubMed 39624017

  • Gjefsen E, Braten LCH, Goll GL, Wigemyr M, Bolstad N, Valberg M, Schistad EI, Marchand GH, Granviken F, Selmer KK, Froholdt A, Haugen AJ, Dagestad MH, Vetti N, Bakland G, Lie BA, Haavardsholm EA, Nilsen AT, Holmgard TE, Kadar TI, Kvien T, Skouen JS, Grovle L, Brox JI, Espeland A, Storheim K, Zwart JA. 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. BMC Musculoskelet Disord. 2020 Oct 21;21(1):698. doi: 10.1186/s12891-020-03720-5.

    PubMed 33087100

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biosimilar Infliximab in people with Low Back Pain, run by Oslo University Hospital at 6 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Oswestry Disability Index (ODI) from baseline to 5 months (time frame: 0, 1, 2, 3, 4, 5 and 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03704363, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.

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