Skip to content

Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial)

Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial) - Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial)

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000005724
Enrollment
30
Registered
2011-06-29
Start date
2011-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis complicated by sjogren&#39

Interventions

None listed

Sponsors

Division of Clinical Immunology, Major of Advanced Biochemical Applications, Graduate School of Comprehensive Human Science,University of Tsukuba Takayuki Sumida
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)20 years-old< 2)Rheumatoid arthritis patinets according to criteria of ACR1987 or ACR/EULAR2010 3)Sjogren's syndrome patients according to criteria of the 1999 Ministry of Health and Welfare 4)Patients with subjective sicca symptoms 5) Patients who give a full consent to this study

Exclusion criteria

Exclusion criteria: 1)contraindicated patients 2)patients over 75 years of age 3)Patients with a total leukocyte count of 3000/mm3 or less, 4)pregnant women or lactating mothers, women with child-bearing potential and patients wishing to become pregnant during this study 5)patients under 20 years of age 6)patients who had received any drugs for treatment of Sjogren's syndrome, including cevimeline hydrochloride hydrate, anetholtrithion, and pilocarpine hydrochloride within 4 weeks prior to the study treatment 7) patients with any concurrent serious disorders of the liver, kidney or hematopoietic organs 8) anti centromere antibody positive 9)Patients who are inadequate by investigator's decision.

Design outcomes

Primary

MeasureTime frame
Remission at year 1,defined as a SDAI of less than 3.3

Secondary

MeasureTime frame
1) CRP,ESR,RF 2) Saxon test 3) salivary glands MRI 4) Immunoglobulins, the anti-SS-A/Ro antibody, the anti-SSB/La antibody 5) Patients VAS 6) Joint Radiographic assessment 7) Joint Magnetic resonance imaging assessment 8) ultrasonography

Countries

Japan

Contacts

Public ContactIsao Matsumoto

Graduate School of Comprehensive Human Science,University of Tsukuba Division of Clinical Immunology,Mejor of Advanced Biochemical Applications

rinshokenkyu@un.tsukuba.ac.jp029-853-3900

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026