Inflammatory Bowel DiseasesArthralgieMICINCT02899871
Joint Pain Occurring During Anti-TNF Therapy in Chronic Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
IBD (inflammatory bowel disease) are associated with various types of joint manifestations, especially inflammatory. Patients with IBD treated with anti-TNF commonly report joint symptoms, with variable expressions and aetiologies, possibly responsible for impaired quality of life, and possibly leading to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- diagnosis of joint
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with IBD (Crohn's disease or ulcerative colitis),
Who may be able to join
- Males or females over the age of 18 years at the time of inclusion
- Patients with IBD (Crohn's disease or ulcerative colitis), diagnosed by a set of compatible clinical (chronic diarrhoea, haematochezia, anoperineal lesions, etc.), laboratory, histological and endoscopic arguments. Patients will be included regardless of the severity of their disease, its clinical course, the type of lesions, and the presence or absence of associated manifestations.
- Patients treated with anti-TNF: infliximab or adalimumab.
- Informed patients not refusing to participate.
- Patients covered by French national health insurance.
Who cannot join
- Patients under the age of 18 years at the time of inclusion.
- Patients previously treated with anti-TNF, but no longer treated with anti-TNF at the time of inclusion.
- Protected majors (under permanent or temporary guardianship).
Trial locations and contacts
1 site in 1 country.
About this study
IBD (inflammatory bowel disease) are associated with various types of joint manifestations, especially inflammatory. Patients with IBD treated with anti-TNF commonly report joint symptoms, with variable expressions and aetiologies, possibly responsible for impaired quality of life, and possibly leading to discontinuation of an effective and validated treatment.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- diagnosis of joint
- Keywords
- joint pain
- Medical subject headings
- Inflammatory Bowel Diseases, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis of jointOther
The diagnosis of joint pain will be established by a rheumatologist and completed:
- If necessary, by a clinically guided radiological assessment (plain x-rays, joint ultrasound, bone and joint MRI).
- serum assays of the anti-TNF administered, as well as screening for associated antibodies.
| Study group | Role | What they receive |
|---|---|---|
| Control | patients treated with anti-TNF not presenting any joint symptoms. Receives: Other: diagnosis of joint | |
| case | aetiology of joint symptoms Receives: Other: diagnosis of joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of joint pain
presence or absence : The diagnosis of joint pain will be established by a rheumatologist and completed:
- If necessary, by a clinically guided radiological assessment (plain x-rays, joint ultrasound, bone and joint MRI).
- serum assays of the anti-TNF administered, as well as screening for associated antibodies.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis DUPAS, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899871
- Sponsor's protocol ID
- PI2014_843_0016
- Acronym
- ArthralgieMICI
- Status last verified
- Aug 2018
- First submitted
- 5 Sep 2016
- Last updated
- 10 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Pain Occurring During Anti-TNF Therapy in Chronic Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02899871
- Acronym / sponsor ID
- ArthralgieMICI / PI2014_843_0016
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- joint pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
IBD (inflammatory bowel disease) are associated with various types of joint manifestations, especially inflammatory. Patients with IBD treated with anti-TNF commonly report joint symptoms, with variable expressions and aetiologies, possibly responsible for impaired quality of life, and possibly leading to discontinuation of an effective and validated treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: diagnosis of jointpatients treated with anti-TNF not presenting any joint symptoms. |
| case | – | Other: diagnosis of jointaetiology of joint symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with IBD (Crohn's disease or ulcerative colitis),
Key inclusion criteria (5 listed)
- Males or females over the age of 18 years at the time of inclusion
- Patients with IBD (Crohn's disease or ulcerative colitis), diagnosed by a set of compatible clinical (chronic diarrhoea, haematochezia, anoperineal lesions, etc.), laboratory, histological and endoscopic arguments. Patients will be included regardless of the severity of their disease, its clinical course, the type of lesions, and the presence or absence of associated manifestations.
- Patients treated with anti-TNF: infliximab or adalimumab.
- Informed patients not refusing to participate.
- Patients covered by French national health insurance.
Key exclusion criteria (3 listed)
- Patients under the age of 18 years at the time of inclusion.
- Patients previously treated with anti-TNF, but no longer treated with anti-TNF at the time of inclusion.
- Protected majors (under permanent or temporary guardianship).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosis of jointThe diagnosis of joint pain will be established by a rheumatologist and completed: * If necessary, by a clinically guided radiological assessment (plain x-rays, joint ultrasound, bone and joint MRI). * serum assays of the anti-TNF administered, as well as screening for associated antibodies. | Other | Control, case |
Primary outcome
Diagnosis of joint pain
Time frame: 1 year
presence or absence : The diagnosis of joint pain will be established by a rheumatologist and completed: * If necessary, by a clinically guided radiological assessment (plain x-rays, joint ultrasound, bone and joint MRI). * serum assays of the anti-TNF administered, as well as screening for associated antibodies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis DUPAS, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of joint pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.