Comorbidities and Outcomes in Early Rheumatoid Arthritis

NCT03675516 | Completed Results DMC

• 1 other identifier: P001
• Study Type: observational
• Target: 13,182
• Locations: 1 country
• Sites: 1

Brief Summary

Identify the burden of comorbidity at the time of diagnosis of rheumatoid arthritis. Identify the impact of comorbidity present at diagnosis on cardiovascular disease, death, rheumatoid arthritis disease progression and infections.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure

  From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of myocardial infarction, stroke, or heart failure (whichever came first) or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).

• Event Rate for a Composite of Incident Infections.

  The composite will comprise incident upper respiratory tract infections, bronchitis, influenza-like illnesses, pneumonia, intestinal infectious diseases, herpes simplex, skin and soft tissue infections, urinary tract infections, and genital and perineal infections

  From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of infection or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).

Secondary Outcomes (3)

• Event Rate for Incident Stroke

  From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of stroke or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).

• Event Rate for Incident Heart Failure

  From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of heart failure or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).

• Event Rate for a Joint Operations Composite, Comprised of Incident Joint Operations on Shoulder, Elbow, Wrist, Hand, Hip, Knee, Ankle and Foot

  From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of joint operation to follow-up or until 1st January 2017 (maximum follow-up: 13 years).

Study Arms (2)

Rheumatoid arthritis cases

New onset cases of rheumatoid arthritis

Other: No specific intervention

Controls

Age, gender and primary care practice-matched controls

Other: No specific intervention

Interventions

No specific intervention OTHER

Usual care

Controls; Rheumatoid arthritis cases

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed rheumatoid arthritis identified from their primary care records.

You may qualify if:

• Diagnosis of rheumatoid arthritis prior to 1st January 2017
• Aged ≥18 years old

You may not qualify if:

• Patients with another other rheumatic disease

Sponsors & Collaborators

• Momentum Data: lead

Study Sites (1)

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

Location

Related Publications (3)

• Nikiphorou E, de Lusignan S, Mallen CD, Khavandi K, Bedarida G, Buckley CD, Galloway J, Raza K. Cardiovascular risk factors and outcomes in early rheumatoid arthritis: a population-based study. Heart. 2020 Oct;106(20):1566-1572. doi: 10.1136/heartjnl-2019-316193. Epub 2020 Mar 24.

  PMID: 32209618 RESULT

• Nikiphorou E, de Lusignan S, Mallen C, Roberts J, Khavandi K, Bedarida G, Buckley CD, Galloway J, Raza K. Prognostic value of comorbidity indices and lung diseases in early rheumatoid arthritis: a UK population-based study. Rheumatology (Oxford). 2020 Jun 1;59(6):1296-1305. doi: 10.1093/rheumatology/kez409.

  PMID: 31580449 RESULT

• Nikiphorou E, de Lusignan S, Mallen C, Khavandi K, Roberts J, Buckley CD, Galloway J, Raza K. Haematological abnormalities in new-onset rheumatoid arthritis and risk of common infections: a population-based study. Rheumatology (Oxford). 2020 May 1;59(5):997-1005. doi: 10.1093/rheumatology/kez344.

  PMID: 31501866 RESULT

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

Limitations and Caveats

No data was available on mortality - this outcome was therefore dropped from the analysis

Results Point of Contact

• Title: Dr Andrew McGovern
• Organization: Momentum Data

andy.mcgovern@momentumdata.co.uk

+447531221970

Study Officials

• Andy McGovern, BSc

  Momentum Data

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 18, 2018
• Study Start: March 1, 2004
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 25, 2023
• Results First Posted: March 15, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)