NCT03473912

Brief Summary

Serum, synovial fluid and skin biopsies from patients will be collected to the biobank with rheumatoid diseases. These samples will later be used for clinical and basic research, following approval of each specific study by the IRB. The investigators intend to extract protein, DNA and RNA from each sample.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
140mo left

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Apr 2018Nov 2037

First Submitted

Initial submission to the registry

September 10, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
19.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2037

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2037

Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

19.6 years

First QC Date

September 10, 2017

Last Update Submit

March 7, 2019

Conditions

Rheumatoid ArthritisLupus Erythematosus, SystemicSystemic SclerosisIgG4-related DiseaseSjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

  • collecting samples

    IgG4-related disease patients

    20 years

Study Arms (4)

RA patients

before or after medication

Systemic sclerosis patients

before or after medication

IgG4 RD patients

before or after medication

Lupus patients

before or after medication

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients of our rheumatological clinic which have a rheumatolid condition and are willing to sign an informed consent.

You may qualify if:

  • above 18 years of age
  • willing to sign informed consent
  • have a rheumatoid condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, synovial fluid and skin biopsies.

MeSH Terms

Conditions

Arthritis, RheumatoidLupus Erythematosus, SystemicScleroderma, SystemicImmunoglobulin G4-Related DiseaseSjogren's Syndrome

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSkin DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Yair Levy, Prof.

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yair Levy, Prof.

CONTACT

972-9-7471524levy.yair@clalit.org.il

Noa Rabinowicz, Dr.

CONTACT

972-9-7471992noa.rabinowicz@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2017

First Posted

March 22, 2018

Study Start

April 16, 2018

Primary Completion (Estimated)

November 1, 2037

Study Completion (Estimated)

November 1, 2037

Last Updated

March 11, 2019

Record last verified: 2019-03

Locations

IL(1)