Condition category
Signs and Symptoms
Date applied
01/09/2016
Date assigned
21/09/2016
Last edited
07/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Lower back pain is a common problem, which affects most people at some point in their lives. Many people who experience LBP will recover quickly with no significant impact to their lives, but for some people the pain turns into a long term condition which can affect their ability to work. When a sufferer experiences episodes which last for at least three months, it is known as chronic lower back pain (CLBP). For some patients, their CLBP is caused by inflammation (swelling) in the vertebrae (small bones which make up the spite). Adalimumab is a medication used in patients with inflammatory conditions such as arthritis, as it works by reducing inflammation. The aim of this study is to investigate the effectiveness of treating patients who have CLBP caused by inflammation with adalimumab.

Who can participate?
Adults with CLBP which is caused by inflammation.

What does the study involve?
All participants receive a subcutaneous injection (injection under the skin) of 40mg Adalimumab every other week for 12 weeks. During this time, and for two weeks after the end of treatment, participants are askedto keep a record of any pain medication they take, which is reviewed at the start of the study, each time they have an injection and two weeks after the end of treatment. At the start of the study and then after 12 weeks, participants complete a number of questionnaires to assess their pain levels and disability. In addition, participants also have an MRI scan at the start of the study and after 12 weeks to measure the swelling (inflammation) in their spine).

What are the possible benefits and risks of participating?
Participants may benefit from a reduction in pain and disability. There is a small risk that participants may be more vulnerable to developing an infection while taking the study drug.

Where is the study run from?
1. University Hospital of Geneva (Switzerland)
2. HFR- Fribourg Cantonal Hospital (Switzerland)

When is the study starting and how long is it expected to run for?
July 2010 to January 2015

Who is funding the study?
1. University Hospital of Geneva (Switzerland)
2. AbbVie (USA)

Who is the main contact?
Dr Stéphane Genevay
stephane.genevay@hcuge.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stéphane Genevay

ORCID ID

http://orcid.org/0000-0003-4752-3186

Contact details

Division of Rheumatology
University Hospitals of Geneva
Geneva
1211
Switzerland
+41 223 723 673
stephane.genevay@hcuge.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CE 10 139

Study information

Scientific title

Anti-TNF treatment in patients with chronic low back pain associated with Modic I changes: An exploratory trial

Acronym

Study hypothesis

Adalimumab could be a potentiel treatment for low back pain patient with Modic I endplate changes.

Ethics approval

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

Study design

Pilot one-arm non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Intervention

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.

Intervention type

Drug

Phase

Phase IV

Drug names

Adalimumab (Humira)

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

07/07/2010

Overall trial end date

23/01/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant 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

Recruitment start date

02/06/2013

Recruitment end date

24/10/2014

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital of Geneva
Division of Rheumatology
Geneva
1211
Switzerland

Trial participating centre

HFR- Fribourg Cantonal Hospital
Department of Rheumatology, Physical Medicine and Rehabilitation
Fribourg
1708
Switzerland

Sponsor information

Organisation

Universtity Hostpital of Geneva

Sponsor details

Perret-Gentil 4
Geneva
1211
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of Geneva

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AbbVie

Alternative name(s)

AbbVie Inc., AbbVie U.S., Abbvie

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Results will be presented in rheumatology and back pain congress. They will then be published in peer-reviewed journals.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes