Adalimumab in low back pain

• Register: ISRCTN
• Last refreshed on: 8 June 2020
• Main ID: ISRCTN15955788
• Date of registration: 21/09/2016
• Prospective Registration: No
• Primary sponsor: University Hospital of Geneva
• Public title: Adalimumab in low back pain
• Scientific title: Anti-TNF treatment in patients with chronic low back pain associated with Modic I changes: An exploratory trial
• Date of first enrolment: 02/06/2013
• Target sample size: 25
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15955788
• Study type: Interventional
• Study design: Pilot one-arm non-randomised study (Treatment)
• Phase: Phase IV

Countries of recruitment

Switzerland

Contacts

• Name: Stéphane Genevay

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic low back pain patient with inflammatory pain pattern and Modic I endplate changes
Signs and Symptoms
Chronic low back pain patient with inflammatory pain pattern and Modic I endplate changes

Intervention(s)

All patients receive a subcutaneous injection of Adalimumab 40mg every other week for 12 weeks.

Participants are asked to keep a pain medication diary from baseline until 2 weeks after the intervention, which is reviewed at baseline and then every 2 weeks until the final follow up 2 weeks after the intervention ends. Participants complete follow up questionnaires and undergo MRI scanning at 12 weeks.

Primary Outcome(s)

Pain is measured using a numerical rating scale (NRS) and the Roland Disability Questionnaire (RDQ) at baseline and 12 weeks.

Secondary Outcome(s)

1. Morning stiffness is measured using a numerical rating scale (NRS) at baseline and 12 weeks
2. Quality of sleep is measured using a numerical rating scale (NRS) at baseline and 12 weeks
3. Patient Global Improvement is measured using a numerical rating scale (NRS) at baseline and 12 weeks
4. Function is measured using Bath Ankylosing Spondilitis disease activity index (BASDAI) at baseline and 12 weeks
5. Health related quality of life is measured using the EuroQol-5 dimensions (EQ-5D) at baseline and 12 weeks
6. Pain medication taken is measured using the Pain Medication Diary at baseline and then every 2 weeks until 2 weeks post-intervention
7. Duration of sick listing is measured by questionnaire at baseline and 2 weeks post-intervention
8. Size of bone oedema is measured using MRI (Modic I) at baseline and 12 weeks

Secondary ID(s)

CE 10 139

Source(s) of Monetary Support

University Hospital of Geneva, AbbVie

Ethics review

Status:
Approval date:
Contact:

1. Ethical committee of Geneva University Hospital, 09/11/2011, ref: 10-139 2. Swissmedic, 16/12/2011, ref: 2011DR2213

Results

• Results available: Yes
• Date Completed: 23/01/2015