Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

JRCT ID: jRCTs031180001

Registered date:12/06/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 30/05/2016
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Infliximab Withdrawal

Outcome(s)

• Primary Outcome: Difference in diagnostic value (AUC of ROC) to predict relapse between DAS28 and total PD score at baseline

Secondary Outcome

Predictive values
- DAS28 at baseline
- total PD/GS scores at baseline
- clinical outcomes other than relapse
- structural progression (delta van der Heijde [vdH] Sharp score)
- physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI])
- quality of life (EuroQoL 5 dimensions [EQ-5D]-5L QOL)
Efficacy and safety after re-administration of infliximab
- DAS28, EULAR response
- adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) 18 years or older
2) RA patients who fulfill 2010 ACR/EULAR Classification Criteria
3) Patients who have been treated with infliximab (Remicade) for 26 weeks or longer
4) DAS28 (CRP) < 3.2 at screening
5) Patients who give written informed consent after receiving sufficient information

Exclude criteria

1) Receiving prednisolone > 10 mg/day
2) Receiving biological or molecular-target anti-rheumatic drug
3) Alteration of the dose of corticosteroid or anti-rheumatic drug within 8 weeks prior to screening visit
4) Alteration of the dose of non-steroid anti-inflammatory drug within 4 weeks prior to screening visit
5) History of infusion reaction to infliximab
6) Current infection which requires treatment
7) Current or previous demyelinating disorder
8) Current congestive heart failure which requires treatment
9) Breast-feeding or pregnant/possibly pregnant woman, or woman who does not agree to prevent conception during and 6 months after study period
10) Patients whom investigator or co-investigator consider inappropriate for other reasons

Related Information

• Primary Sponsor: Ikeda Kei
• Source(s) of Monetary Support: Mitsubishi Tanabe Pharma Corporation
• Secondary ID(s): UMIN000021929,NCT02770794