Adalimumab in low back pai

Phase 4

Completed

• Conditions: Chronic low back pain patient with inflammatory pain pattern and Modic I endplate changes; Signs and Symptoms

• Registration Number: ISRCTN15955788
• Lead Sponsor: niversity Hospital of Geneva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-01-23
• Study Start: 2016-09-21
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Age 18-65 years
2. Signed Informed Consent
3. Common low back pain
4. The presence of 2 out of 3 of the following points, indicating inflammatory back pain:
4.1. Insidious onset
4.2. Morning stiffness
4.3. Improvement with exercise
5. Continuous pain for more than 3 months
6. Failure of at least one full course of non steroidal anti-inflammatory drug
7. Pain > 3/10 on a 0 to 10 numeric rating scale over the last 24 hours
8. At least one Modic I modification on lumbar MRI

Exclusion Criteria

1. A diagnosis of spondylarthropathy following standard definition
2. Either : Presence of sacroiliitis on imaging
or At least 2 of the following
Inflammatory Bowel Disease, Arthritis, Enthesitis, Dactylitis, Uveitis, Psoriasis, Family history of spondylarthropathy, Elevated CRP or sedimentation rate
3. Radicular pain related to disc herniation
4. Neurogenic claudication related to lumbar stenosis
5. Comorbidities impairing with the evaluation of pain or function
6. Concomitant infection
6.1. In case of tuberculosis (positive TBspot) at least one month of antituberculosis treatment is required before considering inclusion
6.2. Active Hepatitis B infection (screening for active HBV infection will be performed)
7. Women of child-bearing age refusing to use contraceptive measure during the study, Pregnancy (pregnancy test will be performed before inclusion), breastfeeding
8. Heart failure (NYHA III and IV)
9. Current treatment with corticosteroids
10. Prior exposure to anti-TNF agents, including adalimumab
11. Inability to comply with the protocol requirements
12. Past history of cancer
13. Demyelinating diseases
14. Allergy to adalimumab or one of its components
15. Unable to read and understand the questionnaires (in French)
16. Poor motivation or other emotional or intellectual problems that are likely to limit the ability of the patient to comply with the protocol requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified