NCT02012764

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jan 2007Jun 2026

Study Start

First participant enrolled

January 1, 2007

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

19.5 years

First QC Date

November 8, 2013

Last Update Submit

March 25, 2025

Conditions

Inflammatory ArthritisRheumatoid Arthritis

Keywords

Anti-CCP antibodyInflammatory arthritisRheumatoid arthritisMusculoskeletal symptom

Outcome Measures

Primary Outcomes (1)

  • Anti-CCP Ab (+).

    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 (+).

    12 years

Secondary Outcomes (5)

  • Anti-CCP positive developing I.A

    1 year

  • Anti-CCP positive developing RA

    1 year

  • Presenting complaints

    1 week

  • Predictors for the development of an IA.

    12 years

  • First degree familymembers who are anti-CCP Ab (+)

    10 years

Study Arms (1)

Musculoskeletal symptoms - Pre diagnosis

Patients presenting with non-specific musculoskeletal complaints at risk of development of RA.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • GP and Musculoskeletal referred patients:
  • Subjects with any of the following conditions or characteristics will be excluded
  • Patients with clinical synovitis
  • Patient fulfils 1987 ACR Criteria or the 2010 ACR/EULAR criteria for RA
  • Rheumatology clinic referred patients:
  • Subjects with any of the following conditions or characteristics will be excluded
  • Patient has tested CCP Ab negative
  • Patient fulfils 1987ACR Criteria or the 2010 ACR/EULAR criteria for RA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chapel Allerton Hospital : Leeds Institute of Rheumatic and Musculoskeletal Medicine

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

Related Publications (6)

  • Garcia-Montoya L, Kang J, Duquenne L, Di Matteo A, Nam JL, Harnden K, Chowdhury R, Mankia K, Emery P. Factors associated with resolution of ultrasound subclinical synovitis in anti-CCP-positive individuals with musculoskeletal symptoms: a UK prospective cohort study. Lancet Rheumatol. 2024 Feb;6(2):e72-e80. doi: 10.1016/S2665-9913(23)00305-3.

    PMID: 38267105DERIVED

  • Garcia-Montoya L, Nam JL, Duquenne L, Villota-Eraso C, Di Matteo A, Hartley C, Mankia K, Emery P. Prioritising referrals of individuals at-risk of RA: guidance based on results of a 10-year national primary care observational study. Arthritis Res Ther. 2022 Jan 18;24(1):26. doi: 10.1186/s13075-022-02717-w.

    PMID: 35042555DERIVED

  • Ouboussad L, Hunt L, Hensor EMA, Nam JL, Barnes NA, Emery P, McDermott MF, Buch MH. Profiling microRNAs in individuals at risk of progression to rheumatoid arthritis. Arthritis Res Ther. 2017 Dec 22;19(1):288. doi: 10.1186/s13075-017-1492-9.

    PMID: 29273071DERIVED

  • Nam JL, Hensor EM, Hunt L, Conaghan PG, Wakefield RJ, Emery P. Ultrasound findings predict progression to inflammatory arthritis in anti-CCP antibody-positive patients without clinical synovitis. Ann Rheum Dis. 2016 Dec;75(12):2060-2067. doi: 10.1136/annrheumdis-2015-208235. Epub 2016 Jan 22.

    PMID: 26802181DERIVED

  • Nam JL, Hunt L, Hensor EM, Emery P. Enriching case selection for imminent RA: the use of anti-CCP antibodies in individuals with new non-specific musculoskeletal symptoms - a cohort study. Ann Rheum Dis. 2016 Aug;75(8):1452-6. doi: 10.1136/annrheumdis-2015-207871. Epub 2015 Sep 22.

    PMID: 26395501DERIVED

  • Rakieh C, Nam JL, Hunt L, Hensor EM, Das S, Bissell LA, Villeneuve E, McGonagle D, Hodgson R, Grainger A, Wakefield RJ, Conaghan PG, Emery P. Predicting the development of clinical arthritis in anti-CCP positive individuals with non-specific musculoskeletal symptoms: a prospective observational cohort study. Ann Rheum Dis. 2015 Sep;74(9):1659-66. doi: 10.1136/annrheumdis-2014-205227. Epub 2014 Apr 12.

    PMID: 24728331DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

ArthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Paul Emery

    University of Leeds

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ARUK Professor of Rheumatology

Study Record Dates

First Submitted

November 8, 2013

First Posted

December 16, 2013

Study Start

January 1, 2007

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations

GB(1)