Rheumatoid Arthritis Response to Methotrexate | NCT03535519

Studies
Rheumatoid Arthritis Response to Methotrexate

NCT03535519

Sponsor

Juan Carlos Nieto

Status

Unknown status

Last Update Posted

Aug 7, 2019Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Methotrexate

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 7, 2018Actual

Primary Completion Date

Aug 31, 2020Estimated

Completion Date

Aug 31, 2020Estimated

First Submitted Date

May 14, 2018

First Submission Date that Met QC Criteria

May 14, 2018

First Posted Date

May 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2019

Last Update Posted Date

Aug 7, 2019Actual

Name	Class
Nordic Pharma SAS	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methotrexate	Drug	standard of care treatment with methotrexate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ultrasound response	Change in B mode and Doppler mode synovitis and tenosynovitis	Basal and at 6 months

Secondary Outcomes

Measure	Description	Time Frame
Clinical response	Change in disease activity measured by DAS28, CDAI and SDAI	Basal and 6 months
Functional response	Change in functional status measured by HAQ

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Rheumatoid arthritis fulfilling EULAR criteria with active disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Juan Carlos Nieto González, PhD	Contact	+34637723549		juancarlos.nietog@gmail.com

Overall Officials

Name	Affiliation	Role
Juan Carlos Nieto González, PhD	Hospital General Universitario Gregorio Maranon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital General Universitario Gregorio Marañón	Recruiting	Madrid		28007	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008727	Methotrexate

Ancestor Terms

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided