NCT02012764Active, not recruiting
The CCP Study: Coordinated Programme to Prevent Arthritis - Can We Identify Arthritis at a Pre-clinical Stage ?
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
This is a 12-month, prospective, observational cohort trial involving Primary Care Trusts (PCTs) wishing to take part in the study and the Early Arthritis Clinic (Anti-CCP sub-clinic) at Chapel Allerton Hospital. The approximate duration of subject participation will be 12 months and the approximate total duration of the study will be 10 years. Patients who have not developed inflammatory arthritis within the 12 month period will have the opportunity to continue follow up within the clinic on an annual basis with additional visits as clinically indicated until the development of IA.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 4000 (estimated)
- First submitted
- 8 Nov 2013
- Start date
- Jan 2007
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- University of Leeds
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT02012764
What you commit to
- Study type: Observational
- Planned participants: 4000
- From Jan 2007 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects with any of the following conditions or characteristics will be excluded
Lab values
- For the MRI imaging component, the following exclusions will apply; pacemaker, surgical clips within the head, certain inner ear implants, neuro-electrical stimulators or metal fragments within the eye or head or eGFR \< 45 ml/min/1.73 m2. In patients with previous penetrating trauma to the eye, or patients at high risk of previous metal foreign body injury to the eye (e.g. welding), skull x-ray will be performed; these patients may be included in the absence of residual metal fragments on x-ray.
- Rheumatology clinic referred patients:
- Subjects with any of the following conditions or characteristics will be excluded
- For the MRI imaging component, the following exclusions will apply; pacemaker, surgical clips within the head, certain inner ear implants, neuro-electrical stimulators or metal fragments within the eye or head or eGFR \< 45 ml/min/1.73 m2. In patients with previous penetrating trauma to the eye, or patients at high risk of previous metal foreign body injury to the eye (e.g. welding), skull x-ray will be performed; these patients may be included in the absence of residual metal fragments on x-ray.
Other
- GP and Musculoskeletal referred patients:
- Patients with clinical synovitis
- Patient fulfils 1987 ACR Criteria or the 2010 ACR/EULAR criteria for RA
- Patient has tested CCP Ab negative
- Patient fulfils 1987ACR Criteria or the 2010 ACR/EULAR criteria for RA
Who the study is looking for
- For the purpose of this study, "musculoskeletal complaint" is defined as any new joint / muscular symptoms, including (but not limited to)
- Rotator cuff tendonitis / subacromial bursitis
- Carpal tunnel syndrome
- Tendonitis e.g. epicondylitis "New" complaint is defined as a symptom in which the patient has not previously reported to their GP.
- GP and Musculoskeletal referred patients:
- Subject must fulfil all of the following conditions or characteristics in order to be considered for study enrolment or participation:
- Is age \> 18 years
- Has a new musculoskeletal complaint or has a family member with RA
- Is capable of understanding and signing an informed consent form
- Rheumatology Clinic referred patients:
- Subject must fulfil all of the following conditions or characteristics in order to be considered for study enrolment or participation:
- Is age \> 18 years
- Has a new musculoskeletal complaint
- Is capable of understanding and signing an informed consent form
- Has tested CCP Ab positive
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chapel Allerton Hospital : Leeds Institute of Rheumatic and Musculoskeletal Medicine Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.