PREVALENCE OF Anti-CCP POSITIVITY AND SUBCLINICAL SIGNS OF INFLAMMATION IN PATIENTS WITH NEW ONSET OF NON-SPECIFIC MUSCULOSKELETAL SYMPTOMS

NCT03267147 | Completed

• 1 other identifier: TMP-1016_01
• Study Type: observational
• Target: 986
• Locations: 1 country
• Sites: 1

Brief Summary

Non-interventional, prospective, observational study to assess the relative risk of anti-CCP positive patients to develop (subclinical) signs of inflammation in accordance with early Rheumatoid Arthritis (RA) in a population without pre-classified RA but new1 onset of non-specific musculoskeletal (MSK) symptoms in general practices in Germany and subsequent 36 months follow-up by rheumatologists

Conditions

Rheumatoid Arthritis

Keywords

Anti-CCP; rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Determination of the relative risk in patients with new onset of non-specific MSK symptoms who are anti-CCP positive to develop (subclinical) signs of inflammation in accordance with early RA in general practices in Germany

  Determination if RA symptoms are present

  every 6 months up to 3 years

Secondary Outcomes (21)

• diagnosis of RA in the group of anti-CCP positive patients with new onset of non-specific MSK symptoms

  every 6 months up to 3 years

• subclinical signs of inflammation using routine examination methods in anti-CCP positive patients

  every 6 months up to 3 years

• subclinical signs of inflammation using fluorescence optical imaging technique in anti-CCP positive patients

  every 6 months up to 3 years

• subclinical signs of inflammation using ultrasound in anti-CCP positive patients

  every 6 months up to 3 years

• anti-CCP level over time in anti-CCP positive patients

  over 3 years

Study Arms (2)

antiCCP positive

Patients with a positive result in the anti-CCP quick test and positive in antiCCP ELISA will be examined by Rheumatologist for detection of RA symptoms and followed-up for 3 years or until RA diagnosis no intervention is given

Other: no intervention is given

antiCCP negative

Patient with negative result in antiCCP quick test or negative antiCCP ELISA will be followed-up after one year (and 3 years for ELISA negative patients) with a short questionnaire if musculoskeletal symptoms are still present or if RA was diagnosed

Other: no intervention is given

Interventions

no intervention is given OTHER

no intervention is given

antiCCP negative; antiCCP positive

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

population without pre-classified RA but new onset of non-specific musculoskeletal (MSK) symptoms

You may qualify if:

• New onset of non-specific MSK symptoms, including, but not limited to, arthralgia of the hands and the large joints such as wrists, knees, and shoulders
• Written informed consent obtained prior to the initiation of any study protocol-required procedures
• General understanding of study procedure and informed consent
• Age ≥ 18 and ≤ 65 years

You may not qualify if:

• RA diagnosed according to modified EULAR/ACR (american college of rheumatology)-criteria
• Other known arthritis
• Other known reasons for MSK symptoms, e.g. mechanical, traumatic, etc.
• MSK symptoms previously reported at another (general) practice
• Alcohol, drug or chemical abuse
• Underage or incapable patients

Sponsors & Collaborators

• Fraunhofer Institute for Translational Medicine and Pharmacology ITMP: lead
• Bristol-Myers Squibb: collaborator
• Goethe University: collaborator

Study Sites (1)

CIRI

Frankfurt am Main, Hessia, 60596, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Frank Behrens, MD

  Fraunhofer IME

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical research department

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: August 30, 2017
• Study Start: April 27, 2017
• Primary Completion: December 16, 2021
• Study Completion: February 15, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

DE (1)