NCT04702295

Brief Summary

30 months, multicentre, prospective observational study on adult (\>18 years) patients with a diagnosis of rare and complex connective tissue diseases (rCTDs) who will be given the vaccine during the period from January 2021 and January 2022. Patients with the following diagnosis will be included:

  • antiphospholipid syndrome (APS),
  • Ehlers-Danlos syndrome (EDS),
  • idiopathic inflammatory myopathies (IIM),
  • IgG4-related disease (IgG4),
  • mixed connective tissue disease (MCTD),
  • relapsing polychondritis (RP),
  • Sjogren's syndrome (SS),
  • systemic lupus erythematosus (SLE),
  • systemic sclerosis (SSc)
  • undifferentiated connective tissue disease (UCTD)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 5, 2021

Last Update Submit

January 7, 2021

Conditions

Connective Tissue DiseasesRare DiseasesRheumatologic Disorder

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events (any type)

    12 months

  • COVID-19 incidence in patients with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen - cases confirmed ≥7 days after the last dose

    12 months

Secondary Outcomes (7)

  • Incidence of disease flare post-vaccination

    12 months

  • Incidence of serious adverse events

    12 months

  • Incidence of life-threatening adverse events and deaths

    12 months

  • Incidence of adverse events of special interest for COVID-19

    12 months

  • Clinical variables (age, sex, underlying disease, ongoing treatment, comorbidities) associated with COVID-19 occurrence during the post-vaccination follow-up

    12 months

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult (\>18 years) patients with a diagnosis of rCTDs who will be given the vaccine during the period from January 2021 and January 2022.

You may qualify if:

  • Patients with the following diagnosis will be included:
  • antiphospholipid syndrome (APS),
  • Ehlers-Danlos syndrome (EDS),
  • idiopathic inflammatory myopathies (IIM),
  • IgG4-related disease (IgG4),
  • mixed connective tissue disease (MCTD),
  • relapsing polychondritis (RP),
  • Sjogren's syndrome (SS),
  • systemic lupus erythematosus (SLE),
  • systemic sclerosis (SSc)
  • undifferentiated connective tissue disease (UCTD)

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Connective Tissue DiseasesRare DiseasesCollagen Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor in Rheumatology

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 8, 2021

Study Start

February 1, 2021

Primary Completion

February 1, 2023

Study Completion

August 1, 2023

Last Updated

January 8, 2021

Record last verified: 2021-01