Rheumatoid ArthritisNCT00781469
A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood
An observational study of Rheumatoid Arthritis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Rheumatoid arthritis is a systemic disease, it is not clear whether the gene expression profile exhibited by circulated peripheral blood cells and that expressed by the inflamed synovium mirror one another. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2008to Oct 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult men and non-pregnant, non-lactating women between 18 and 75 years of age with a clinical history of rheumatoid arthritis.
Who may be able to join
- Adult men and non-pregnant, non-lactating women between 18 and 75 years of age. Sexually active females must be of either non-childbearing potential or willing to comply with the contraceptive requirements
- Body weight greater >40 kg and <120 kg with a body mass index (BMI) between 19-31 kg/m2
- Clinical history of rheumatoid arthritis as defined by ACR criteria
- Negative urine pregnancy test for women of child bearing age (except those with documented proof of hysterectomy or bilateral oophorectomy)
- For populations B and C only
- Currently on a stable dosing regimen of methotrexate 7.5 to 25 mg once weekly, as their only DMARD (no changes in dosing regimen for 4 weeks prior to screening).
Who cannot join
- History of an acute illness within 2 weeks prior to the study
- History of drug abuse within 2 years
- Donation of blood in excess of 500 mL within 56 days prior to the first dose of study medication
- For group A only
- Prior treatment with disease modifying anti-rheumatic agents or biologicals.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital
London, W6 8RF
About this study
Rheumatoid arthritis is a systemic disease, it is not clear whether the gene expression profile exhibited by circulated peripheral blood cells and that expressed by the inflamed synovium mirror one another. Understanding this relationship would be useful not only in potentially having a relatively non-invasive means to predict response to therapy but it might be useful in better understanding differences in RA expression amongst patients with this disease, thus perhaps assisting in target identification through a better understanding of disease processes.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease affecting approximately 1% of the adult population. The disease is characterised by inflammation of synovial tissue (ST) in multiple joints, which often leads to destruction of joint integrity, contributing to serious functional impairment and disability. The contributors to its pathology include joint inflammation, abnormal cellular and humoral responses, and synovial hyperplasia. Ultrasonography is a powerful, non-invasive, and feasible way to evaluate synovial hyperplasia and guide its collection by biopsy.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, RNA, Synovium, Peripheral blood mononuclear cells
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Naive patients | 12 treatment naive patients who fulfil the American College of Rheumatology (ACR) criteria for RA with active disease defined by a Disease Activity Score (DAS)28 score of more than 3.2. | |
| Patients in remission | 6 RA patients in remission on a stable dose of methotrexate with a DAS28 score lower than 2.6 | |
| Patients still have active disease | 12 patients who fulfill the ACR criteria for RA and are being treated with methotrexate but still have active disease, defined as a DAS28 score of more than 3.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral blood markers from patients with rheumatoid arthritis correlate to findings on ultrasound images and synovium (joint lining).
Measured: Initial visit
Secondary outcomes (1)
Gene expression pattern of synovium in treatment naive rheumatoid arthritis patients correlates to that found in their circulating blood cells and if these are affected (or not)by disease modifying therapy (DMARD).
Measured: Visits 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: struggled to recruit and the synovial tissue samples obtained were so poor that we had to end the study prematurely without data from the primary outcomes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Peter C Taylor, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781469
- Sponsor's protocol ID
- 112009
- Status last verified
- Feb 2021
- First submitted
- 28 Oct 2008
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood
- ClinicalTrials.gov ID
- NCT00781469
- Acronym / sponsor ID
- 112009
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, RNA, Synovium, Peripheral blood mononuclear cells
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: struggled to recruit and the synovial tissue samples obtained were so poor that we had to end the study prematurely without data from the primary outcomes
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2008 (actual)
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Oct 2008 (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.
Rheumatoid arthritis is a systemic disease, it is not clear whether the gene expression profile exhibited by circulated peripheral blood cells and that expressed by the inflamed synovium mirror one another. Understanding this relationship would be useful not only in potentially having a relatively non-invasive means to predict response to therapy but it might be useful in better understanding differences in RA expression amongst patients with this disease, thus perhaps assisting in target identification through a better understanding of disease processes.
Detailed description
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease affecting approximately 1% of the adult population. The disease is characterised by inflammation of synovial tissue (ST) in multiple joints, which often leads to destruction of joint integrity, contributing to serious functional impairment and disability. The contributors to its pathology include joint inflammation, abnormal cellular and humoral responses, and synovial hyperplasia. Ultrasonography is a powerful, non-invasive, and feasible way to evaluate synovial hyperplasia and guide its collection by biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naive patients | – | –12 treatment naive patients who fulfil the American College of Rheumatology (ACR) criteria for RA with active disease defined by a Disease Activity Score (DAS)28 score of more than 3.2. |
| Patients in remission | – | –6 RA patients in remission on a stable dose of methotrexate with a DAS28 score lower than 2.6 |
| Patients still have active disease | – | –12 patients who fulfill the ACR criteria for RA and are being treated with methotrexate but still have active disease, defined as a DAS28 score of more than 3.2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men and non-pregnant, non-lactating women between 18 and 75 years of age with a clinical history of rheumatoid arthritis.
Key inclusion criteria (6 listed)
- Adult men and non-pregnant, non-lactating women between 18 and 75 years of age. Sexually active females must be of either non-childbearing potential or willing to comply with the contraceptive requirements
- Body weight greater >40 kg and <120 kg with a body mass index (BMI) between 19-31 kg/m2
- Clinical history of rheumatoid arthritis as defined by ACR criteria
- Negative urine pregnancy test for women of child bearing age (except those with documented proof of hysterectomy or bilateral oophorectomy)
- For populations B and C only
Key exclusion criteria (5 listed)
- History of an acute illness within 2 weeks prior to the study
- History of drug abuse within 2 years
- Donation of blood in excess of 500 mL within 56 days prior to the first dose of study medication
- For group A only
- Prior treatment with disease modifying anti-rheumatic agents or biologicals.
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
Peripheral blood markers from patients with rheumatoid arthritis correlate to findings on ultrasound images and synovium (joint lining).
Time frame: Initial visit
1 secondary outcome
Gene expression pattern of synovium in treatment naive rheumatoid arthritis patients correlates to that found in their circulating blood cells and if these are affected (or not)by disease modifying therapy (DMARD).
Time frame: Visits 1, 2 and 3
Results and safety
The study was stopped early (reason given: struggled to recruit and the synovial tissue samples obtained were so poor that we had to end the study prematurely without data from the primary outcomes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Peter C Taylor, PhD principal investigator
Imperial College London
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 Rheumatoid Arthritis, run by Imperial College London at 1 site in United Kingdom.
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 6 inclusion and 5 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 12 Feb 2021. 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 United Kingdom. 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: struggled to recruit and the synovial tissue samples obtained were so poor that we had to end the study prematurely without data from the primary outcomes). 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?
Peripheral blood markers from patients with rheumatoid arthritis correlate to findings on ultrasound images and synovium (joint lining). (time frame: Initial visit). 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 12 Feb 2021.