A Prospective Pilot Study to Explore Efficacy and Safety of Baricitinib in Active Primary Sjogren's Syndrome Patients

Plain-language summary

This pilot study explores the effectiveness and safety of the drug Baricitinib in patients with active primary Sjogren's syndrome. People with moderate or high disease activity who meet the 2016 ACR/EULAR classification criteria could take part. It was carried out as a Phase 1/Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Completed

Sponsor

Peking Union Medical College Hospital

Intervention

Baricitinib 2 MG

Start date

1/16/2020

Estimated completion

3/25/2021

Countries

China

Related genes

Locations

• Beijing, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. fulfill the criteria of the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification for primary SS
2. with moderate or high activity of SS, which was defined as EULAR primary SS disease activity index (ESSDAI) ≥5
3. with serological activity defined as elevated C-reactive protein, erythrocyte sedimentation rate (ESR), and/or immunoglobulin G (IgG) level (excluding acute and chronic infection and other factors)

Exclusion Criteria:

1. patients diagnosed with an active central nervous system disease or dysfunction of a major organ (heart, liver, kidney)
2. pregnant or lactating women
3. current severe infections
4. undergoing glucocorticoids or immunosuppressants treatment with stable dosage for less than 12 weeks