Comparison of effects of baricitinib and sarilumab on arthralgia in patients with rheumatoid arthritis
- Conditions
- joint painD001172
- Registration Number
- JPRN-jRCT1031230107
- Lead Sponsor
- Ogasawara Michihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Patients aged 18 years or older at the time of informed consent
2. Gender : Any
3. Treatment categories : outpatient/inpatient
4. Patients diagnosed with RA according to the ACR/EULAR Rheumatoid Arthritis Classification Criteria (2010)
5. Patients with moderate or greater disease activity (DAS28-ESR >= 3.2) at the time of eligibility assessment at enrollment
6. Patients with a pain VAS > 40 mm at enrollment
7. Patients with inadequate response to MTX who have been continuously treated with MTX for at least 8 weeks at the time of enrollment and have been receiving the same dose of 8 - 16 mg/week for at least 4 weeks (however, doses less than 8 mg/week are allowed only if there is intolerance to 8 mg/week or more)
8. Patients who have given written informed consent of their own free will after receiving sufficient explanation about participating in this study
Patients who meet any one of the following criteria are excluded from the study.
1. Patients taking corticosteroids exceeding 5 mg/day equivalent to prednisolone
2. Patients with contraindications for baricitinib or sarilumab
3. Patients who have used JAK inhibitors and IL-6 inhibitors in the past
4. patients who have had a dose change of csDMARDs or corticosteroids within 4 weeks of enrollment
5. patients treated with a TNF inhibitor (infliximab, infliximab BS, adalimumab, adalimumab BS, golimumab, certolizumab pegol or ozoralizumab) or abatacept within 8 weeks of enrollment
6. patients treated with a TNF inhibitor (etanercept, etanercept BS) within 4 weeks of enrollment
7. patients using concomitant or concomitant prohibited therapies other than csDMARDs and the above-mentioned biologic agents within 4 weeks of enrollment
8. Diseases with joint symptoms other than RA (ankylosing spondylitis, reactive arthritis, psoriatic arthritis, crystal-induced arthritis, systemic lupus erythematosus, systemic scleroderma, inflammatory muscle disease, mixed connective tissue disease) patients with
9. Patients with cervical hernia, herpes zoster, diabetic neuropathy, and other diseases that cause neuropathic pain due to organic disorders
10. Patients with primary diagnosis of fibromyalgia
11. patients with psychotic disorders (e.g., schizophrenia, schizoaffective disorder, paranoid disorder), patients receiving treatment with selective serotonin reuptake inhibitors, monoamine oxidase inhibitors Patients receiving treatment with tricyclic, tetracyclic, or atypical antidepressants.
12. patients being treated with opioid analgesics.
13. patients treated with the investigational drug within the past 3 months.
14. patients with severe renal disease (serum creatinine level > 2.0 mg/dL)
15. patients with severe hepatic impairment (AST or ALT > 100 U/L)
16. lactating, pregnant, or trying to become pregnant, or patients who are unable to provide consent to use contraception from the time of eligibility assessment for 12 months after the last dose
17. Other patients who are deemed inappropriate as research subjects by the principal investigator (subinvestigator)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ACR20 response rate at 12 weeks
- Secondary Outcome Measures
Name Time Method Central sensitization inventory<br>Tender joint count<br>swollen joint count<br>Patient pain VAS<br>Patient global VAS<br>Patient global VAS<br>DAS28ESR, DAS28CRP SDAI, CDAI<br>pain Detect<br>MPQ, McGill Pain Questionnaire<br>Pain catastrophizing scale<br>HADS, Hospital Anxiety and Depression scale<br>FACIT-F<br>Athens Insomnia Scale<br>EQ-5D<br>ADL, HAQ-DI<br>RF, ACPA, MMP-3<br>X-ray examination of both hands and toes<br>ACR50 response rate, ACR70 response rate<br>Musculoskeletal ultrasound score