Photodynamic Therapy For Synovial Hyperplasia in Patients With Refractory Rheumatoid Arthritis : A Study Protocol For A Randomised Double-Blind Blank-Controlled Prospective Trial

Abstract

\n 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.