The CCP Study: Coordinated Programme to Prevent Arthritis - Can We Identify Arthritis at a Pre-clinical Stage ? (CCP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02012764|
Recruitment Status : Recruiting
First Posted : December 16, 2013
Last Update Posted : June 30, 2016
|Condition or disease|
|Inflammatory Arthritis Rheumatoid Arthritis|
There is accumulating evidence for the need to identify patients with rheumatoid arthritis (RA) early. Damage occurs early and early treatment is effective. Clearly there is a need to improve ways of identifying these patients.
It is recognised that patients with RA often have non-specific musculoskeletal complaints in the months or years prior to development of RA (unpublished observations). Family members of patients with RA are also at greater risk of developing RA.
Given we know that earlier identification of patients enables earlier treatment and this leads to better long-term outcomes, we need a method of identifying patients at the pre-clinical stage of disease.
C-reactive protein (CRP) is an acute phase reactant, produced by the liver, primarily in response to stimulation by interleukin-6 (IL-6). The lower limit of detection of routine CRP is 8mg/dL (or higher), yet the mean CRP in the general population is <2mg/dL11 (as measured by high sensitivity assays). Therefore, patients with early RA may have low-grade inflammation not detected by routine CRP. This has been demonstrated in patients with established disease12, but no studies have been done in early disease. Disease activity variables correlated with increases in highly-sensitive CRP (hs-CRP) and hs-CRP was better than ESR at predicting disease activity and severity12. Interestingly, on retrospective analysis of blood donor serum, increased levels of hs-CRP have been noted in RA patients during the pre-clinical phase, most commonly within the two years prior to symptom onset13. This suggests immunologic changes occur prior to the development of the symptomatic stage and provides an exciting tool for assisting in the diagnosis of very early inflammatory disease
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|Official Title:||The CCP Study: Coordinated Programme to Prevent Arthritis - Can We Identify Arthritis at a Pre-clinical Stage ?|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Musculoskeletal symptoms - Pre diagnosis
Patients presenting with non-specific musculoskeletal complaints at risk of development of RA.
- Anti-CCP Ab (+). [ Time Frame: 12 years ]The primary objective of this study is to determine the proportion of community patients with new-onset, non-specific musculoskeletal complaints who are anti-CCP Ab (+).
- Anti-CCP positive developing I.A [ Time Frame: 1 year ]
Secondary objectives in this study include:
1. The number of anti-CCP positive patients who develop an inflammatory arthritis by 12 months / after 12 months.
- Defined as symptoms and signs of synovitis.
- Synovitis is defined as the presence soft tissue swelling and at least 1 of the following 2 criteria; tenderness or decreased range of motion.
- Anti-CCP positive developing RA [ Time Frame: 1 year ]The number of anti-CCP positive patients who develop RA by 12 months/ after 12 months (defined by 1987 ACR and the 2010 ACR/EULAR criteria).
- Presenting complaints [ Time Frame: 1 week ]To document the initial presenting complaint of all patients (anti-CCP positive and negative)
- Predictors for the development of an IA. [ Time Frame: 12 years ]
To determine usefulness of hs-CRP in predicting development of an IA in patients with positive anti-CCP Ab.
To determine usefulness of MRI and HRUS in predicting development of an IA in patients with positive anti-CCP Ab.
- First degree familymembers who are anti-CCP Ab (+) [ Time Frame: 10 years ]To determine the percentage of people with family members who have RA who are anti-CCP Ab (+)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012764
|Chapel Allerton Hospital : Leeds Institute of Rheumatic and Musculoskeletal Medicine||Recruiting|
|Leeds, West Yorkshire, United Kingdom, LS7 4SA|
|Contact: Paul Emery 0113 3924844 email@example.com|
|Contact: Jackie Nam 0113 3924844 firstname.lastname@example.org|
|Principal Investigator: Paul Emery|
|Sub-Investigator: Jackie Nam|
|Sub-Investigator: Laura Hunt|
|Study Chair:||Paul Emery||University of Leeds|