Tofacitinib in the treatment of primary Sjögren’s syndrome-associated interstitial lung disease: study protocol for a prospective, randomized, controlled and open-label trial

Table 1 Outline of planned visit

	STUDY PERIOD							Follow-up of patients with early termination
	Screening Visit	Randomize	Treatment Visits					Follow-up of patients with early termination
TIMEPOINT**	Visit 1 *-4w* ~ 0		Visit 2 Day 0	Visit 3–7 Week 4–20	Visit 8 Week 24	Visit 9–12 Week 28–44	Visit 13 Week 52
Eligibility screen	✔							✔
Informed consent	✔							✔
Adverse event check				✔	✔	✔	✔	✔
Study drug			✔	✔	✔	✔	✔	✔
Concomitant medication			✔	✔	✔	✔	✔	✔
ASSESSMENTS:
Physical exam	✔			✔	✔	✔	✔	✔
ESSDAI score	✔				✔		✔	✔
Cough symptom score			✔	✔	✔	✔	✔	✔
HARQoL score			✔	✔	✔	✔	✔	✔
Mahler dyspnea index	✔			✔	✔	✔	✔	✔
6-MWT			✔	✔	✔	✔	✔	✔
Routine laboratory examination	✔			✔	✔	✔	✔	✔
C3, C4, IgA, IgG, IgM, IgG4			✔	✔	✔	✔	✔	✔
Autoimmune antibody spectrum			✔		✔		✔	✔
CD series cells			✔		✔		✔	✔
Arterial blood gas	✔			✔	✔	✔	✔	✔
Pulmonary function	✔				✔		✔	✔
Chest CT	✔				✔		✔	✔

Abbreviation: ESSDAI EULAR Sjögren's syndrome disease activity index, HARQoL Health-related quality of life, 6-MWT 6-min walk test, C3 Complement 3, C4 Complement 4, IgA immunoglobulin A, IgG Immunoglobulin G, IgM Immunoglobulin M, IgG4 Immunoglobulin G4, CT Computed tomography

ISSN: 1471-2466