- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03704363
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Bergen, Norway
- Haukeland University Hospital
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Drammen, Norway
- Vestre Viken Hospital Trust Drammen
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Moss, Norway
- Østfold Hospital Trust
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Oslo, Norway, 0407
- Oslo University Hospital Ullevål
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Tromsø, Norway
- University Hospital of North Norway
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Trondheim, Norway
- St. Olavs Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion criteria:
- 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).
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Infliximab
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.
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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.
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Placebo Comparator: Placebo
Intravenous infusion (NaCl intravenous infusion).
Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98.
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Intravenous infusion.
Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98,
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Oswestry Disability Index (ODI) from baseline to 5 months
Time Frame: 0, 1, 2, 3, 4, 5 and 9 months
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ODI is a disease-specific disability score.
Scale is measured 0-100, better to worse respectively.
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0, 1, 2, 3, 4, 5 and 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Short tau inversion recovery (STIR) signal (intensity and extent) of Modic Changes from baseline to 5 months.
Time Frame: 0 and 5-6 months
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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.
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0 and 5-6 months
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Change in low back pain intensity from baseline to 5 months
Time Frame: 0 + weekly during intervention period, 3, 5 and 9 months
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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.
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0 + weekly during intervention period, 3, 5 and 9 months
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Change in Roland Morris Disability Questionnaire (RMDQ) from baseline to 5 months
Time Frame: 0, 3, 5 and 9 months
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RMDQ is a Self-reported disease-specific disability score, scale 0-24, better to worse respectively.
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0, 3, 5 and 9 months
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Change in Health-related quality of life from baseline to 5 months
Time Frame: 0, 3, 5 and 9 months
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EuroQoL-5D-5L (version 2.0), range -0.59 to 1.0, worse to better respectively.
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0, 3, 5 and 9 months
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Number and type of co-interventions (other pharmacological treatment (ATC-coded) and non-pharmacological treatment)
Time Frame: Will be registered every month up to 5 months and at 9 months
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Will be reported by patients monthly during the study period for health-economical calculations
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Will be registered every month up to 5 months and at 9 months
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Days with sick leave
Time Frame: Will be registered at baseline and monthly until last follow-up
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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).
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Will be registered at baseline and monthly until last follow-up
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Incidence of adverse events (AEs) and serious AE (SAEs) during the study period
Time Frame: 2, 6, 14, 22 and 40 weeks after start of treatment
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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.
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2, 6, 14, 22 and 40 weeks after start of treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Leg pain intensity from baseline to 5 months
Time Frame: 0, 3, 5 and 9 months
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Numeric Rating Scale (NRS: 0-10, better to worse respectively); leg pain last week.
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0, 3, 5 and 9 months
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Change in Hours with low back pain during the last 4 weeks from baseline to 5 months
Time Frame: 0, 3, 5 and 9 months
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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).
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0, 3, 5 and 9 months
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Change in Symptom-specific well-being from baseline to 5 months
Time Frame: 0, 3, 5 and 9 months
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Measured on a 5-point Likert scale with 'very satisfied', 'some satisfied', 'neither satisfied nor dissatisfied', 'some dissatisfied' or 'very dissatisfied'
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0, 3, 5 and 9 months
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Patients' satisfaction
Time Frame: Will be measured at 3, 5 and 9 months after start of treatment
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Rated on a 5-point Likert scale; patients rate satisfaction with treatment
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Will be measured at 3, 5 and 9 months after start of treatment
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Global perceived effect from baseline
Time Frame: Will be measured at 3, 5 and 9 months after start of treatment
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Global Rating of Change is rated on a 7-point Likert scale to quantify a patient's self-judged improvement from baseline.
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Will be measured at 3, 5 and 9 months after start of treatment
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Perceived treatment
Time Frame: Seven days after start of treatment, post-treatment (14 weeks after start of treatment) and at 5 months after start of treatment
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Patients will be asked about which study medicine (Infliximab / placebo / unsure) they think they received during the intervention period of the study.
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Seven days after start of treatment, post-treatment (14 weeks after start of treatment) and at 5 months after start of treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne Froholdt, PhD, Vestre Viken Hospital Trust Drammen
- Principal Investigator: Anne Julsrud Haugen, PhD, Ostfold Hospital Trust
- Principal Investigator: Jan Sture Skouen, PhD, Haukeland University Hospital
- Principal Investigator: Jens Ivar Brox, PhD, Oslo University Hospital
- Principal Investigator: Gunn Hege Marchand, PhD, St. Olavs Hospital, Trondheim
- Principal Investigator: Gunnstein Bakland, PhD, University Hospital of North Norway Tromsø
- Study Chair: John-Anker Zwart, PhD, Oslo University Hospital, Oslo, Norway
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/2450
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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