BackToBasic: Infliximab in Chronic Low Back Pain and Modic Changes
Ключевые слова
абстрактный
Описание
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.
Даты
| Последняя проверка: | 04/30/2020 |
| Первый отправленный: | 09/18/2018 |
| Предполагаемая регистрация отправлена: | 10/10/2018 |
| Первое сообщение: | 10/11/2018 |
| Последнее обновление отправлено: | 05/26/2020 |
| Последнее обновление опубликовано: | 05/28/2020 |
| Фактическая дата начала исследования: | 12/11/2018 |
| Предполагаемая дата завершения начальной школы: | 04/30/2021 |
| Предполагаемая дата завершения исследования: | 09/30/2021 |
Состояние или болезнь
Вмешательство / лечение
Drug: Infliximab
Other: Placebo
Фаза
Группы рук
| Рука | Вмешательство / лечение |
|---|---|
| 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. | Drug: Infliximab 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. |
| 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. | Other: Placebo Intravenous infusion. Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98, |
Критерии приемлемости
| Возраст, имеющий право на обучение | 18 Years Чтобы 18 Years |
| Полы, имеющие право на обучение | All |
| Принимает здоровых добровольцев | да |
| Критерии | 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 |
Результат
Основные показатели результатов
1. Change in Oswestry Disability Index (ODI) from baseline to 5 months [0, 1, 2, 3, 4, 5 and 9 months]
Меры вторичного результата
1. Change in Short tau inversion recovery (STIR) signal (intensity and extent) of Modic Changes from baseline to 5 months. [0 and 5-6 months]
2. Change in low back pain intensity from baseline to 5 months [0 + weekly during intervention period, 3, 5 and 9 months]
3. Change in Roland Morris Disability Questionnaire (RMDQ) from baseline to 5 months [0, 3, 5 and 9 months]
4. Change in Health-related quality of life from baseline to 5 months [0, 3, 5 and 9 months]
5. Number and type of co-interventions (other pharmacological treatment (ATC-coded) and non-pharmacological treatment) [Will be registered every month up to 5 months and at 9 months]
6. Days with sick leave [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 [2, 6, 14, 22 and 40 weeks after start of treatment]
Другие показатели результатов
1. Change in Leg pain intensity from baseline to 5 months [0, 3, 5 and 9 months]
2. Change in Hours with low back pain during the last 4 weeks from baseline to 5 months [0, 3, 5 and 9 months]
3. Change in Symptom-specific well-being from baseline to 5 months [0, 3, 5 and 9 months]
4. Patients' satisfaction [Will be measured at 3, 5 and 9 months after start of treatment]
5. Global perceived effect from baseline [Will be measured at 3, 5 and 9 months after start of treatment]
6. Perceived treatment [Seven days after start of treatment, post-treatment (14 weeks after start of treatment) and at 5 months after start of treatment]
