PRECISion medicinE Across the Disease Continuum to Prevent and Treat Rheumatoid Arthritis

NCT04482335 | Unknown

• 1 other identifier: 281253
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The study will recruit patients referred to the Rheumatology Out-patient departments. Patients will be recruited to the study or control groups (healthy or disease controls who will be age and sex-matched) as needed. The study will first open to recruitment at Manchester University Hospitals NHS Foundation Trust and then open at other NHS Trusts. Patients will be asked to participate in longitudinal (clinical/imaging/biosample) data and/or sample collection that will improve our understanding of underlying disease mechanisms and identify improved diagnostic, prognostic and predictive biomarkers to understand progression of disease and drug response or resistance.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• • Main study - Change in Disease Activity Score in 28 Joints (DAS28)

  • The Disease Activity Score (DAS) assessment is a derived measurement with differential weight given to each component. The DAS28 is calculated at every visit. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment (0-100). The components of the DAS28 CRP score assessment are: Tender/Painful Joint Count (28); Swollen Joint Count (28), CRP, and the Subject General Health VAS assessment (0-100). The DAS score ranges from 0-10 and higher scores indicate high disease activity. A DAS28 value of \>5.1 indicates high disease activity, 3.2 \<DAS28 ≤5.1 and DAS28 ≤3.2 are defined as moderate and low disease activity. Patients may be considered to be in remission phase if DAS28 is \<2.6

  through to study completion, an average of 2 years

• • Biosample substudy - Change in serum biomarkers, gene expression and the distribution of cell populations in biological samples (peripheral blood, synovial fluid, urine) using ELISA, sequencing, flow cytometry and CyTOF

  • Biosample substudy - Change in serum biomarkers, gene expression and the distribution of cell populations in biological samples (peripheral blood, synovial fluid, urine) using ELISA, sequencing, flow cytometry and CyTOF

  through to study completion, an average of 2 years

• • Synovial biopsy substudy - Changes in immunological markers of inflammation in synovial tissue

  • Synovial biopsy substudy - Changes in immunological markers of inflammation in synovial tissue

  Baseline +/- week 12 or 24 after change in therapy

Secondary Outcomes (12)

• • Change in Patient reported outcome measure - Rheumatoid Arthritis Quality of Life (RAQoL)

  through to study completion, an average of 2 years

• • Change in Patient reported outcome measure - Health Assessment Questionnaire (HAQ)

  through to study completion, an average of 2 years

• • Change in Patient reported outcome measure - EuroQoL (EQ-5D)

  through to study completion, an average of 2 years

• • Change in Patient reported outcome measure - Functional Assessment of Chronic Illness Therapy - fatigue (FACIT-fatigue)

  through to study completion, an average of 2 years

• • Change in Patient reported outcome measure - Hospital Anxiety and Depression Scale (HADs)

  through to study completion, an average of 2 years

Study Arms (3)

Main Study

Participants complete questionnaires and agree to have their retrospective and prospective medical data used as part f this research project. All participants will take part in this arm.

Other: No intervention

Biosample Sub-Study

A subset of the participants will take part of this. Participants will agree to have blood samples taken at regular intervals or at the point of a flare or when their treatment changes. They might also be asked to provide urine samples.

Other: No intervention

Synovial Biopsy and Synovial Fluid Sub-Study

A subset of the participants will take part of this. Participants will agree to synovial biopsies at regular intervals or at the point of a flare or when their treatment changes. They might also be asked to donate waste synovial fluid.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Biosample Sub-Study; Main Study; Synovial Biopsy and Synovial Fluid Sub-Study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with early rheumatoid arthritis

You may qualify if:

• Subject ≥ 18 years of age
• Is capable of understanding and signing an informed consent form
• Falls into one of the following:
• Pre-RA - Any musculoskeletal symptom (inflammatory and/or non-inflammatory) AND either RF and/orACPA positive.
• UA - Inflammatory joint symptoms (including joint pain, significant early morning stiffness and joint swelling) not fulfilling any classification criteria
• ERA - recent clinical diagnosis of RA EstRA - known diagnosis of RA supported by evidence of established inflammatory arthritis including but not limited to synovitis, erosion, tenosynovitis.

You may not qualify if:

• Age less than 18 years
• Lack of capacity to give informed consent

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Manchester Royal Infirmary

Manchester, Greater Manchester, M13 9WL, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A maximum of 75mls of blood may be taken to enable the range of experimental studies. The blood may be drawn into a combination of EDTA, lithium heparin, red clotted, citrate and PAXGENE/TEMPUS tubes, according to planned experiments at each time point. Samples will be collected fasting at specific timepoints if indicated. Similarly, synovial fluid may also be aspirated from a clinically inflamed joint (usually as part of clinical indication), and used for research purpose. Urine samples may also be collected (usually as part of clinical indication), and used for research purpose.

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 Design

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

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: July 22, 2020
• Study Start: May 15, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)