Rheumatoid ArthritisNCT02528292
Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
This study will be an open label observational prospective study assessing the clinical efficacy of antiTNFα therapy and the alteration/impact on the synovial tissue, with specific regard to lymphoid aggregation, over a period of 12 months in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Synovial biopsy and Anti-TNF therapy
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Apr 2018
- 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 within Rheumatology secondary care services with active Rheumatoid Arthritis will be recruited
Who may be able to join
- Men and women ≥ 18 and ≤ 75 years of age, with RA as defined by the 1987 revised ACR classification criteria.
- Patients must fulfill the National Institute for Clinical Excellence guidelines for TNF Blocking Therapy in RA.
- Patients must be on MTX for at least 4 months, with a stable dose of 7.525 mg/week for a minimum of 4 weeks.
- Men and women of childbearing potential must use adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study.
- Patients must be able to adhere to the study visit schedule.
- Patients must be capable of giving informed consent and the consent must be obtained prior to any screening procedures.
- Must have a chest Xray within 3 months prior to commencement of antiTNFα with no evidence of malignancy, infection or fibrosis.
Who cannot join
- Women who are pregnant or breast feeding.
- Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
- Previous use of antiTNF biologics.
- Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline, thalidomide, etc.) within 3 months of screening.
- Serious infections (such as, HIV, HBV, pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator.
- Have active TB or have evidence of latent TB (old or latent TB on chest Xray, without adequate therapy for TB initiated prior to first dose of study drug). Also excluded are patients with evidence of an old or latent TB infection without documented adequate therapy.
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- Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening).
- Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or splenomegaly.
- Known recent substance abuse (drug or alcohol).
- Poor tolerability of venepuncture required blood sampling during the study period.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rheumatology Department, Mile End Hospital, Barts and The Royal London NHS Trust
London, London, EH1 4DG
About this study
Official title: Phase 4 Study of Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Patients With Rheumatoid Arthritis Undergoing Treatment With Anti-TNF Therapy
This study will be an open label observational prospective study assessing the clinical efficacy of antiTNFα therapy and the alteration/impact on the synovial tissue, with specific regard to lymphoid aggregation, over a period of 12 months in patients with rheumatoid arthritis.
Rheumatoid arthritis (RA) is one of the most important chronic inflammatory disorders in the UK. It affects approximately 1% of adults and causes considerable morbidity, substantially reduces quality of life and has a significant mortality. It results in large direct medical costs as well as extensive indirect social costs. Despite the significant therapeutic progress following the introduction of antiTNFα, a cure for RA is still elusive. At present the reasons for the variation in clinical response are not known. The main aim of this study is to test the hypothesis that there are distinct molecular and cellular phenotypes present within the synovial tissue that define specific disease subsets and provide characteristic prognostic implications. In particular, the aim is to assess the relationship between the presence of ectopic lymphoneogenesis (ELN) within the rheumatoid synovial membrane and response to antiTNFα therapy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Synovial biopsy, Anti-TNF therapy
- Keywords
- Rheumatoid Arthritis, Anti-TNF, Ultrasound, Synovial histomorphology, Ectopic Lymphoneogenesis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synovial biopsyProcedure or surgery
Ultrasound guided synovial biopsy of inflamed joint
Anti-TNF therapyDrug
Therapy will include, but not limited to Etanercept, Certolizumab Pegol, Adalimumab and Infliximab
| Study group | Role | What they receive |
|---|---|---|
| Active Rheumatoid Arthritis | Patients with active Rheumatoid Arthritis with a DAS 28 score of greater than 5.1 and eligible for anti-TNF alpha therapy according to National Institute for Clinical Excellence guidelines will be recruited in this study Receives: Procedure: Synovial biopsy; Drug: Anti-TNF therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of change in synovial ectopic lymphoneogenesis with EULAR response criteria using DAS28
Measured: Baseline and 12 months
Secondary outcomes (4)
Disability and health status assessed using the HAQ questionnaire
Measured: Baseline and 12 months
X-ray progression
Progression of x-ray damage of hand and feet using modified van der heidje / sharp score
Measured: Baseline and 12 months
Change in synovial histomorphology with treatment
Measured: baseline and 3 months
Correlation of peripheral blood lymphocytes including, Treg markers and, B cell subsets
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startOct 2010
- Primary completionJan 2018 (estimated)
- Study completionApr 2018 (estimated)
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.
- 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
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Costantino Pitzalis, MD, PhD, Principal investigator, Barts and the London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528292
- Sponsor's protocol ID
- UCB-007275
- Status last verified
- Aug 2011
- First submitted
- 5 Aug 2011
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Patients With Rheumatoid Arthritis Undergoing Treatment With Anti-TNF Therapy
- ClinicalTrials.gov ID
- NCT02528292
- Acronym / sponsor ID
- UCB-007275
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Anti-TNF, Ultrasound, Synovial histomorphology, Ectopic Lymphoneogenesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 19 Aug 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.
This study will be an open label observational prospective study assessing the clinical efficacy of antiTNFα therapy and the alteration/impact on the synovial tissue, with specific regard to lymphoid aggregation, over a period of 12 months in patients with rheumatoid arthritis.
Rheumatoid arthritis (RA) is one of the most important chronic inflammatory disorders in the UK. It affects approximately 1% of adults and causes considerable morbidity, substantially reduces quality of life and has a significant mortality. It results in large direct medical costs as well as extensive indirect social costs. Despite the significant therapeutic progress following the introduction of antiTNFα, a cure for RA is still elusive. At present the reasons for the variation in clinical response are not known. The main aim of this study is to test the hypothesis that there are distinct molecular and cellular phenotypes present within the synovial tissue that define specific disease subsets and provide characteristic prognostic implications. In particular, the aim is to assess the relationship between the presence of ectopic lymphoneogenesis (ELN) within the rheumatoid synovial membrane and response to antiTNFα therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Rheumatoid Arthritis | – | Procedure: Synovial biopsy, Drug: Anti-TNF therapyPatients with active Rheumatoid Arthritis with a DAS 28 score of greater than 5.1 and eligible for anti-TNF alpha therapy according to National Institute for Clinical Excellence guidelines will be recruited in this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients within Rheumatology secondary care services with active Rheumatoid Arthritis will be recruited
Key inclusion criteria (7 listed)
- Men and women ≥ 18 and ≤ 75 years of age, with RA as defined by the 1987 revised ACR classification criteria.
- Patients must fulfill the National Institute for Clinical Excellence guidelines for TNF Blocking Therapy in RA.
- Patients must be on MTX for at least 4 months, with a stable dose of 7.525 mg/week for a minimum of 4 weeks.
- Men and women of childbearing potential must use adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study.
- Patients must be able to adhere to the study visit schedule.
Key exclusion criteria (11 listed)
- Women who are pregnant or breast feeding.
- Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
- Previous use of antiTNF biologics.
- Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline, thalidomide, etc.) within 3 months of screening.
- Serious infections (such as, HIV, HBV, pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator.
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 |
|---|---|---|
| Synovial biopsyUltrasound guided synovial biopsy of inflamed joint | Procedure or surgery | Active Rheumatoid Arthritis |
| Anti-TNF therapyTherapy will include, but not limited to Etanercept, Certolizumab Pegol, Adalimumab and Infliximab | Drug | Active Rheumatoid Arthritis |
Primary outcome
Correlation of change in synovial ectopic lymphoneogenesis with EULAR response criteria using DAS28
Time frame: Baseline and 12 months
4 secondary outcomes
Disability and health status assessed using the HAQ questionnaire
Time frame: Baseline and 12 months
X-ray progression
Time frame: Baseline and 12 months
Change in synovial histomorphology with treatment
Time frame: baseline and 3 months
Correlation of peripheral blood lymphocytes including, Treg markers and, B cell subsets
Time frame: baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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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.
Costantino Pitzalis, MD, PhD principal investigator
Barts and the London NHS Trust
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 Barts & The London NHS Trust 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Aug 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 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?
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?
Correlation of change in synovial ectopic lymphoneogenesis with EULAR response criteria using DAS28 (time frame: Baseline and 12 months). 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 19 Aug 2015.