Health TrialsbyHealthPanel

Study of Sirolimus in IgG4-related Disease

ConditionIgG4-related Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University International Hospital

About this trial

gG4-related disease (IgG4-RD) is a newly recognized systemic autoimmune disease that can involve the pan-creatobiliary tract, retroperitoneum/aorta, head and neck region, and salivary glands, et al. Glucocorticoids are the first-line agents for the treatment of IgG4-RD, however, in order to maintain long-term disease stability and avoid disease relapse, glucocorticoids maintenance therapy should last for a long period, which may induce various glucocorticoid-associated adverse reactions. Sirolimus plays dual roles in inhibiting lymphocyte activation and fibroblast proliferation. It is inferred from its mechanism that sirolimus is a good potential treatment option for IgG4-RD. Therefore, we conducted this single-arm clinical trial on patients with IgG4-RD to determine the efficacy and safety of sirolimus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with IgG4-RD according to the 2011 Comprehensive Diagnostic Criteria for IgG4-RD;

Status classified as active disease based on an IgG4-RD Responder Index (RI) ≥2 at screening.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Sirolimus

    Drug

    Sirolimus The efficacy is evaluated at 12 weeks, and treatment will be adjusted according to the control of disease and adverse effects.For experimental group, if a patient is assessed as treatment failure (TS), the patient should be withdrawn from the study and receive rescue treatment. Whereas, a patient would be transferred to the control group if he/ she cann't stand the side effects of sirolimus but not serious adverse event (SAE).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: glucocorticoid and sirolimus combination therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PrRelapse rate

For patients who achieve disease response at 12 weeks, recurrence is defined as increases in the IgG4-RD RI ≥2 and/or the need for the reinstitution of treatment.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Disease response rate at 12 weeks

Disease response is defifined as an improvement of the IgG4-RD RI ≥2 compared with baseline.

Time frame
12 weeks of treatment
2

Remission rate at 48 weeks

Remission is defined as the achievement of an IgG4-RD RI of 0

Time frame
48 weeks of treatment
3

Improvement of patient's global assessment (PGA)

PGA is a validated visual analogue scale that is scored by placing a vertical mark along a 100 mm horizontal line. Zero millimetre indicates no disease activity. A mark of 100 mm indicates the most active disease possible

Time frame
48 weeks of treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University International Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: