FRI0080 Long-term use of enbrel® (etanercept) in patients with dmard-refractory rheumatoid arthritis

Abstract Background Persistent synovial hyperplasia with inflammation in rheumatoid arthritis is the main cause of refractory rheumatoid arthritis (RRA). As a means of local treatment, photodynamic therapy (PDT) confers less trauma, stronger targeting, and more durable curative effects than steroid injections or arthroscopic synovectomy. The aim of this trial will be to evaluate the short-, medium- and long-term clinical efficacy of PDT in the treatment of RRA synovial hyperplasia and synovitis. Methods and analysis This is a single-centre, randomised, double-blind, blank-controlled, prospective trial. A sample of 126 RRA patients will be randomly divided into 3 groups: the control group, the PDT once group, and the PDT twice group, 42 per group. The trial will be conducted at the Rheumatology and Immunology Department of Integrated Hospital of Traditional Chinese Medicine, Southern Medical University. Assessments at baseline, the first operation, the second operation (4th week), and then at three follow-ups (8th week, 24th week, 48th week) will be performed. The Ultrasound Compound Score of Synovitis (UCSS), knee joint clinical assessments, Disease Activity Score in 28 Joints (DAS28), serological inflammation indexes and specific antibody levels, pathological biopsies of synovial tissue and X-ray assessments of bone destruction will be evaluated. An improvement in the UCSS will be the main endpoint, and the UCSS at the 8th week versus the baseline value will reflect the short-term outcome of the operation. The results of the 24th week and 48th week follow-up will reflect the medium- and long-term curative effects, respectively. Ethics and dissemination The protocol was approved by the Medical Ethics Committee of Integrated Hospital of Traditional Chinese Medicine, Southern Medical University, China (Approval No. of the ethics committee: NFZXYEC-2017-005) and later registered in the Chinese Clinical Trials Registry with Registration number ChiCTR1800014918 (approval date: February 21, 2018). All procedures will be in accordance with Chinese laws and regulations, as well as the WMA Declaration of Helsinki. Any modifications to the protocol will be approved by the Ethics Committee of our hospital. Trial registration number ChiCTR1800014918.

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Photodynamic therapy for synovial hyperplasia in patients with refractory rheumatoid arthritis: a study protocol for a randomized, double-blind, blank-controlled prospective trial

Trials ◽

10.1186/s13063-021-05640-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xiaofeng Zhao ◽

Fangfang Zuo ◽

Ensheng Chen ◽

Yanan Bi ◽

Yanyan Cao ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Photodynamic Therapy ◽

Prospective Trial ◽

Ethics Committee ◽

Double Blind ◽

Synovial Hyperplasia ◽

Refractory Rheumatoid Arthritis ◽

Registration Number ◽

Medical University

Abstract Background Persistent synovial hyperplasia with inflammation in rheumatoid arthritis is one of the main pathogeneses of refractory rheumatoid arthritis (RRA). Photodynamic therapy (PDT) causes less trauma than steroid injections or arthroscopic synovectomy while providing stronger targeting and more durable curative effects. The aim of this trial was to evaluate the short-, medium-, and long-term clinical efficacy of PDT when applied as a treatment for RRA synovial hyperplasia and synovitis. Methods and analysis This protocol is for a single-center, randomized, double-blind, blank-controlled prospective trial. A sample of 126 RRA patients will be randomly divided into 3 groups: the control group, the “PDT once” group, and the “PDT twice” group, with 42 participants per group. The trial will be conducted by the Rheumatology and Immunology Department of the Integrated Hospital of Traditional Chinese Medicine, Southern Medical University. The Ultrasound Compound Score of Synovitis (UCSS) has been selected as the primary outcome measure. The secondary outcome measures include knee joint clinical assessments, ratio of relapse, duration of remission, Disease Activity Score in 28 joints (DAS28), inflammation indexes, serum concentrations of specific antibodies, and changes in articular structures as detected by X-ray scans in the 48th week. The improvement ratios of the UCSS at the 8th, 24th, and 48th weeks (compared with baseline) reflect short-, medium-, and long-term time frames, respectively. Ethics and dissemination The protocol was approved by the Medical Ethics Committee of the Integrated Hospital of Traditional Chinese Medicine, Southern Medical University, China (Approval No. granted by the ethics committee: NFZXYEC-2017-005) and then entered in the Chinese Clinical Trials Registry under registration number ChiCTR1800014918 (approval date: February 21, 2018). All procedures are in accordance with Chinese laws and regulations and with the Declaration of Helsinki by the World Medical Association (WMA). Any modifications of this protocol during execution will need additional approval from the Ethics Committee of our hospital. Trial registration number ChiCTR1800014918.

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The long-term remission of rheumatoid arthritis with a single cycle of rituximab

Vojnosanitetski pregled ◽

10.2298/vsp1201078g ◽

2012 ◽

Vol 69 (1) ◽

pp. 78-80

Author(s):

Branislava Glisic ◽

Bojana Knezevic

Keyword(s):

Rheumatoid Arthritis ◽

Case Report ◽

Sustained Remission ◽

Concomitant Treatment ◽

Single Treatment ◽

Single Cycle ◽

Disease Modifying Drugs ◽

Highly Active ◽

Refractory Rheumatoid Arthritis

Introduction. Rituximab selectively targets CD20+ B cells and presumably protects joints in rheumatoid arthritis. Complete remissions after a single treatment with rituximab, in some cases for longer than 1 year, are observed in only the minority of patients. We reported a patient suffering from refractory rheumatoid arthritis who responded to rituximab with sustained remission. Case report. A 78-yearold woman was diagnosed with seropositive rheumatoid arthritis in 2001. The disease remained active despite conventional disease modifying drugs. In February 2007 the disease was highly active. Two infusions of rituximab 1 000 mg on days 1 and 15 were performed. Concomitant treatment consisted of metotrexate 10 mg/week and prednisolone 5 mg/day. The patients were assessed every month after receiving rituximab. Remission was achieved three months later. The patient was retreated with a second cycle of rituximab in December 2009 due to arthritic flare. Conclusion. This case report showed that the rituximab treatment was feasible and led to a clinically relevant and long lasting improvement in disease activity.

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