Abnormality in Synovial TissueNCT02458170
Examination of Biopsies From Healthy Knee Joints
An observational study of Abnormality in Synovial Tissue, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
The purpose of the project is to examine what kind of molecular mechanism which causes inflammatory joint diseases. This examination is carried out by a collection and analysis of synovial tissues for patients without inflammatory joint diseases compared to the experienced equivalent biopsies from patients with… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Abnormality in Synovial Tissue
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Dec 2014
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohorts will be selected from primary care clinic.
Who may be able to join
- Males and females > 18 years
- Planned surgery for patients with meniscus or reconstruction of ligament
Who cannot join
- Employment at Aalborg University Hospital
- Employment at Novo Nordisk A/S
- An unsigned statement of consent
- Current medical treatment resistant to a course of treatment, for example large doses of steroids
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Aalborg University Hospital
Aalborg, DK-9000
About this study
Official title: Examination of Biopsies From Healthy Knee Joints for the Use of Research Activities in Inflammatory Joint Diseases
The purpose of the project is to examine what kind of molecular mechanism which causes inflammatory joint diseases. This examination is carried out by a collection and analysis of synovial tissues for patients without inflammatory joint diseases compared to the experienced equivalent biopsies from patients with inflammatory joint diseases.
Read the detailed description
Arthritis is caused by autoimmune disease in the cells and pathogenesis of the tissue. This autoimmune inflammation is very often a chronic disease which causes irreversible articular damage. Rheumatoid arthritis is very often a painful and disabling disease if the treatment turns out to be ineffectual. Several of the available remedies can not treat the disease totally but only keep the patients in check.
The biological mechanisms which cause an autoimmune inflammatory articular disease have not been proved scientifically yet. Under normal conditions, the immune system adapts easily in order to protect the body against pathogenic bacteria and virus without causing damage on the body's own cells. Autoimmune inflammatory diseases displace this balance in a way so that the immune system can not distinguish between "self" and "non-self". Different kinds of cells are involved in this chronic inflammation in the joints. Majority of these cells belong to the heart of the immune response, for example T-lymphocytes, B-lymphocytes, macrophages, dendrites and granulocytes. However, other cells are also involved, for example synovial fibroblasts and endothelium.
It is very important to understand the interaction of these cells in order to develop new medicinal products for inflammatory articular diseases. The big challenge for conduction research in inflammatory articular diseases is to achieve more evidence-based knowledge of the synovial tissue from the patients and the control group.
- Conditions
- Abnormality in Synovial Tissue
- Keywords
- Rheumatoid arthritis, Synovial tissue, Joint destruction, Inflammation
- Medical subject headings
- Arthritis, Rheumatoid, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events as a measure of metabolism in normal tissue and inflammatory tissue.
Compare the normal metabolism in non-inflammatory tissue with biopsies of inflammatory diseases.
Measured: 7 years
Secondary outcomes (1)
Detect new objects for developing drugs.
Determine potential objects for medical intervention and development of drugs which affect the molecular mechanisms in relation to an inflammatory condition versus a normal metabolic condition.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Shutdown of The Department of Inflammatory Diseases at Novo Nordisk.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormality in Synovial TissueStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D., Study chair, Northern Orthopaedic Division, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458170
- Sponsor's protocol ID
- N-20130026
- Status last verified
- May 2015
- First submitted
- 12 Sep 2014
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Biopsies From Healthy Knee Joints for the Use of Research Activities in Inflammatory Joint Diseases
- ClinicalTrials.gov ID
- NCT02458170
- Acronym / sponsor ID
- N-20130026
- Conditions
- Abnormality in Synovial Tissue
- Keywords
- Rheumatoid arthritis, Synovial tissue, Joint destruction, Inflammation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Shutdown of The Department of Inflammatory Diseases at Novo Nordisk.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Jun 2015 (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.
The purpose of the project is to examine what kind of molecular mechanism which causes inflammatory joint diseases. This examination is carried out by a collection and analysis of synovial tissues for patients without inflammatory joint diseases compared to the experienced equivalent biopsies from patients with inflammatory joint diseases.
Detailed description
Arthritis is caused by autoimmune disease in the cells and pathogenesis of the tissue. This autoimmune inflammation is very often a chronic disease which causes irreversible articular damage. Rheumatoid arthritis is very often a painful and disabling disease if the treatment turns out to be ineffectual. Several of the available remedies can not treat the disease totally but only keep the patients in check.
The biological mechanisms which cause an autoimmune inflammatory articular disease have not been proved scientifically yet. Under normal conditions, the immune system adapts easily in order to protect the body against pathogenic bacteria and virus without causing damage on the body's own cells. Autoimmune inflammatory diseases displace this balance in a way so that the immune system can not distinguish between "self" and "non-self". Different kinds of cells are involved in this chronic inflammation in the joints. Majority of these cells belong to the heart of the immune response, for example T-lymphocytes, B-lymphocytes, macrophages, dendrites and granulocytes. However, other cells are also involved, for example synovial fibroblasts and endothelium.
It is very important to understand the interaction of these cells in order to develop new medicinal products for inflammatory articular diseases. The big challenge for conduction research in inflammatory articular diseases is to achieve more evidence-based knowledge of the synovial tissue from the patients and the control group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohorts will be selected from primary care clinic.
Key inclusion criteria (2 listed)
- Males and females > 18 years
- Planned surgery for patients with meniscus or reconstruction of ligament
Key exclusion criteria (4 listed)
- Employment at Aalborg University Hospital
- Employment at Novo Nordisk A/S
- An unsigned statement of consent
- Current medical treatment resistant to a course of treatment, for example large doses of steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse events as a measure of metabolism in normal tissue and inflammatory tissue.
Time frame: 7 years
Compare the normal metabolism in non-inflammatory tissue with biopsies of inflammatory diseases.
1 secondary outcome
Detect new objects for developing drugs.
Time frame: 7 years
Results and safety
The study was stopped early (reason given: Shutdown of The Department of Inflammatory Diseases at Novo Nordisk.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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.
Sten Rasmussen, M.D. study chair
Northern Orthopaedic Division, Aalborg University Hospital
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 Abnormality in Synovial Tissue, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 1 Jun 2015. 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 Denmark. 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 was stopped early (reason given: Shutdown of The Department of Inflammatory Diseases at Novo Nordisk.). Results are not available in the source record.
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?
Adverse events as a measure of metabolism in normal tissue and inflammatory tissue. (time frame: 7 years). 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 1 Jun 2015.