PROspective sarilumab (preFILled syringe/pen) obsErvational study - Japan (PROFILE-J)
PROFILE-J
Tanaka Yoshiya
University Hospital of Occupational and Environmental Health, Japan
1-1,Iseigaoka,Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-8555, Japan
+81-93-603-1611
tanaka@med.uoeh-u.ac.jp
Hanami Kentaro
University Hospital of Occupational and Environmental Health, Japan
1-1,Iseigaoka,Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-8555, Japan
+81-93-603-1611
hanami@med.uoeh-u.ac.jp
Complete
2000
Observational
1. Adult patients.
2. Patients with diagnosis of Rheumatoid Arthritis according to The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria.
3. Patients for whom the treating physician has made the decision to initiate sarilumab before patient inclusion and independently of the purpose of the study.
4. Study enrollment is to be on the same day as the initiation of treatment or within a maximum of 4 weeks before the initiation of treatment.
5. Signed written informed consent.
1. Patients for whom sarilumab is contra-indicated as described in Japanese package insert.
2. Patients currently participating in any interventional clinical trials.
3. Previous experience with sarilumab through either a clinical trial.
4. Concomitant use of any bDMARDs or any tsDMARDs, including but not limited to etanercept, etanercept BS, adalimumab, adalimumab BS, infliximab, infliximab BS, anakinra, rituximab, rituximab BS, abatacept, tocilizumab, certolizumab, golimumab, tofacitinib, baricitinib, peficitinib, upadacitinib, filgotinib.
5. Previously treated with sarilumab.
6. Uncooperative, or any condition, that could make the patient potentially noncompliant to the study procedures, etc.
20age old over
No limit
Both
Rheumatoid arthritis
Change from baseline* in CDAI at weeks 24 and 52.
*Baseline data are captured at enrollment visit.
Patient characteristics including demographics, prior treatment and prescribed co-medications.
Change from baseline at Weeks 12, 24, 36, and 52:
TJC-28
SJC-28
PrGA-VAS
DAS28 - score (separately for DAS-CRP and DAS-ESR)
SDAI
Laboratory disease parameters:
CRP
ESR
Radiographic outcomes:
Proportion of patients with absence of new bone erosions as per investigator judgement compare to baseline at Week 52, if radiographies are available as per routine practice at baseline visit and at Week 52.
Sarilumab therapy:
Proportion of patients with modification sarilumab therapy scheme (monotherapy and combination-therapy)
Proportion of patients on sarilumab 200 mg or 150 mg.
Modification of dosage (include frequency of administration)
Reasons for adjustments in sarilumab dose associated (but not limited to):
Laboratory abnormalities (Neutropenia, Thrombocytopenia, elevated liver enzymes)
Efficacy
Persistence with treatment or reasons for discontinuation
Patients switching to another treatment for Rheumatoid Arthritis (eg, bDMARD, additional csDMARD, tsDMARD)
Co-medications:
Proportions of patients with:
Dose increase, decrease, no change of csDMARD compared to baseline
No new prescription of csDMARD
Dose increase, decrease, no change in corticosteroid use compared to baseline
No new prescription of corticosteroids
Use of statins (Initiation and dose changing)
Change from Baseline at week 2, 4, 12, 24, 36, and 52 in PROs with respect to physical functioning, morning stiffness, pain, fatigue, PtGA, treatment satisfaction and Work Productivity.
Safety:
Incidences of AEs and laboratory test abnormalities.
