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Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis (OPTIWIT)

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis (OPTIWIT)

211

The median age was 62 years (range:22-87) Male/Female:44/167 Degree of RA:Patients with RA who are on infliximab and who have achieved a remission or present low-disease activity

Recruitment: 211 (Targeted initial sample size: 200) Completed cases: 160 Discontinued cases: 51 (Consent withdrawal: 11 cases, Disease progression: 13 cases, Adverse effect: 7 cases, Doctor judgment 20 cases) Analyzable cases: 200 (No recurrent cases: 108, recurrent cases: 92) (Patient registration period: 4/1/2016 - 30/9/2019)

SAE in this study Death: Treatment related death was not observed. Causal relationship to this study: 2 events (Injection reaction, Pneumonia) No causal relationship to this study: 13 events (Cholecystitis, Bone marrow disorder, Sinus bradycardia, Fever, Gallstone cholangitis, IgA vasculitis, Esophageal achalasia, Acute myeloid leukemia, Exudative serositis, Urinary-tract infection, colorectal cancer progression, Performing meningectomy, Sacral tumor) Other AE in this study: 195 events Heart disorder: 1 event, Labyrinth disorders: 3 events, Eye disorder: 1 event, Gastrointestinal disorders: 12 events, General and administration site condition: 8 events, Hepatobiliary tract disorders: 7 events, Infection: 81 events, Treatment complications: 15 events, Laboratory abnormalities: 5 events, Metabolic and nutritional disorders: 2 events, Skeletal muscle and connective tissue disorders: 25 events, Benign neoplasm: 1 event, Neuropathy: 2 events, Mental illness: 3 events, Kidney and urinary tract disorders: 1 event, Respiratory disorders: 15 events, Skin and subcutaneous tissue disorders: 10 events, Angiopathy: 3 events.

200 of 211 cases were analyzed for primary endpoint. The number of events (relapse) was 92 out of 200. The primary endpoint was to compare the predictive performances of DAS28(CRP) and total PD score. In the ROC analysis, the area under the curve (ACU) for total PD score was larger than the AUC for DAS28(CRP)(0.6047 vs 0.4684) with a statistical significance (p=0.0052, DeLong, DeLong & Clarke-Pearson test).

The result demonstrates that the predictive value of total PD score for relapse is significantly higher than that of DAS28(CRP) in patients with rheumatoid arthritis in low disease activi

Dec. 31, 2022

No

Not applicable

https://jrct.niph.go.jp/latest-detail/jRCTs031180001

Ikeda Kei

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba, Chiba

K.Ikeda@faculty.chiba-u.jp

Ikeda Kei

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba, Chiba

+81-43-222-7171

K.Ikeda@faculty.chiba-u.jp

Complete

May. 01, 2016

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

Rheumatoid arthritis

Infliximab Withdrawal

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

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

+81-43-226-2616

May. 25, 2018

none