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Trial record 41 of 2725 for:    Rheumatoid Arthritis

Comorbidities and Outcomes in Early Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03675516
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Momentum Data

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: No specific intervention

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Study Type : Observational
Actual Enrollment : 13182 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Epidemiology of Cardiovascular Disease, Haematological Abnormalities, and Other Comorbidities in Early Rheumatoid Arthritis in the United Kingdom and Their Associations With Important Outcomes
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Rheumatoid arthritis cases
New onset cases of rheumatoid arthritis
Other: No specific intervention
Usual care

Controls
Age, gender and primary care practice-matched controls
Other: No specific intervention
Usual care




Primary Outcome Measures :
  1. Time to a cardiovascular composite of incident myocardial infarction, stroke, or heart failure [ Time Frame: From diagnosis to loss to follow-up, or 1st January 2017 ]
  2. Time to all cause mortality [ Time Frame: From diagnosis to loss to follow-up, or 1st January 2017 ]
  3. Time to a composite of incident infections. [ Time Frame: From diagnosis to loss to follow-up, or 1st January 2017 ]
    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


Secondary Outcome Measures :
  1. Time to incident myocardial infarction [ Time Frame: From diagnosis to loss to follow-up, or 1st January 2017 ]
  2. Time to incident stroke [ Time Frame: From diagnosis to loss to follow-up, or 1st January 2017 ]
  3. Time to incident heart failure [ Time Frame: From diagnosis to loss to follow-up, or 1st January 2017 ]
  4. Time to an extended cardiovascular composite comprised of incident myocardial infarction, stroke, heart failure, coronary artery disease, percutaneous coronary intervention, and angina [ Time Frame: From diagnosis to loss to follow-up, or 1st January 2017 ]
  5. Time to a joint operations composite comprised of incident joint operations on shoulder, elbow, wrist, hand, hip, knee, ankle and foot [ Time Frame: From diagnosis to loss to follow-up, or 1st January 2017 ]


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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed rheumatoid arthritis identified from their primary care records.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with another other rheumatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675516


Locations
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United Kingdom
Momentum Data Ltd
London, United Kingdom, WC1X 8QT
Sponsors and Collaborators
Momentum Data
Investigators
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Study Director: Andy McGovern, BSc Momentum Data

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Responsible Party: Momentum Data
ClinicalTrials.gov Identifier: NCT03675516     History of Changes
Other Study ID Numbers: P001
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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