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Rheumatoid Arthritis Response to Methotrexate

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03535519
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : August 7, 2019
Nordic Pharma SAS
Information provided by (Responsible Party):
Juan Carlos Nieto, Hospital General Universitario Gregorio Marañon

Brief Summary:
Observational and prospective study of the ultrasound response to methotrexate in rheumatoid arthritis patients who started methotrexate

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Methotrexate

Detailed Description:
  • Rheumatoid arthritis patients with active disease who start subcutaneous methotrexate by their rheumatologist prescription methotrexate will be included.
  • Patients will participate in a prospective and observational study in which the response to methotrexate will be assessed by ultrasound (US) of joints and tendons.
  • The main objective of the study is the change in B mode and Doppler mode US after 24 weeks of methotrexate treatment.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rheumatoid Arthritis Ultrasound Response to Methotrexate
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Methotrexate
    standard of care treatment with methotrexate

Primary Outcome Measures :
  1. Ultrasound response [ Time Frame: Basal and at 6 months ]
    Change in B mode and Doppler mode synovitis and tenosynovitis

Secondary Outcome Measures :
  1. Clinical response [ Time Frame: Basal and 6 months ]
    Change in disease activity measured by DAS28, CDAI and SDAI

  2. Functional response [ Time Frame: Basal and 6 months ]
    Change in functional status measured by HAQ

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rheumatoid arthritis fulfilling EULAR criteria with active disease

Inclusion Criteria:

  • Active rheumatoid arthritis fulfilling EULAR criteria.
  • Prescription of methotrexate by a rheumatologist.
  • Informed consent signed by the patient.

Exclusion Criteria:

  • None

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 identifier (NCT number): NCT03535519

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Contact: Juan Carlos Nieto González, PhD +34637723549

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Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Juan Carlos Nieto González, PhD   
Sponsors and Collaborators
Juan Carlos Nieto
Nordic Pharma SAS
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Principal Investigator: Juan Carlos Nieto González, PhD Hospital General Universitario Gregorio Maranon

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Responsible Party: Juan Carlos Nieto, Principal investigator, Hospital General Universitario Gregorio Marañon Identifier: NCT03535519     History of Changes
Other Study ID Numbers: Reuma-01-2017
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors