Trial record 6 of 3887 for:    "Arthritis"

The CCP Study: Coordinated Programme to Prevent Arthritis - Can We Identify Arthritis at a Pre-clinical Stage ?

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Leeds
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Paul Emery, University of Leeds
ClinicalTrials.gov Identifier:
NCT02012764
First received: November 8, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition
Inflammatory Arthritis
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The CCP Study: Coordinated Programme to Prevent Arthritis - Can We Identify Arthritis at a Pre-clinical Stage ?

Resource links provided by NLM:


Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • Anti-CCP Ab (+). [ Time Frame: 12 years ] [ Designated as safety issue: No ]
    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 (+).


Secondary Outcome Measures:
  • Anti-CCP positive developing I.A [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    To determine the percentage of people with family members who have RA who are anti-CCP Ab (+)


Biospecimen Retention:   Samples With DNA

DNA sample currently retained as part of a sub-study for a departmental tissue bank.


Estimated Enrollment: 2000
Study Start Date: January 2007
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Musculoskeletal symptoms - Pre diagnosis
Patients presenting with non-specific musculoskeletal complaints at risk of development of RA.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients who are attending GP Practices in the Yorkshire and surrounding regions.

Criteria

Inclusion Criteria:

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:

  1. Is age > 18 years
  2. Has a new musculoskeletal complaint or has a family member with RA
  3. 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:

  1. Is age > 18 years
  2. Has a new musculoskeletal complaint
  3. Is capable of understanding and signing an informed consent form
  4. Has tested CCP Ab positive

Exclusion Criteria:

GP and Musculoskeletal referred patients:

Subjects with any of the following conditions or characteristics will be excluded

  1. Patients with clinical synovitis
  2. Patient fulfils 1987 ACR Criteria or the 2010 ACR/EULAR criteria for RA
  3. 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

  1. Patient has tested CCP Ab negative
  2. Patient fulfils 1987ACR Criteria or the 2010 ACR/EULAR criteria for RA
  3. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012764

Locations
United Kingdom
Chapel Allerton Hospital : Leeds Institute of Rheumatic and Musculoskeletal Medicine Recruiting
Leeds, West Yorkshire, United Kingdom, LS7 4SA
Contact: Paul Emery    0113 3924844    p.emery@leeds.ac.uk   
Contact: Jackie Nam    0113 3924844    j.nam@leeds.ac.uk   
Principal Investigator: Paul Emery         
Sub-Investigator: Jackie Nam         
Sub-Investigator: Laura Hunt         
Sponsors and Collaborators
University of Leeds
AbbVie
Investigators
Study Chair: Paul Emery University of Leeds
  More Information

No publications provided

Responsible Party: Paul Emery, ARUK Professor of Rheumatology, University of Leeds
ClinicalTrials.gov Identifier: NCT02012764     History of Changes
Other Study ID Numbers: RR06/7674, 06/Q1205/169
Study First Received: November 8, 2013
Last Updated: December 10, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Leeds:
Anti-CCP antibody
Inflammatory arthritis
Rheumatoid arthritis
Musculoskeletal symptom

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014