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

Trials ◽  
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.

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

2021 ◽  
Author(s):  
Xiaofeng Zhao ◽  
Ensheng CHEN ◽  
Fangfang ZUO ◽  
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 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.

scholarly journals Induction of long-term B-cell depletion in refractory rheumatoid arthritis patients preferentially affects autoreactive more than protective humoral immunity

2012 ◽  
Vol 14 (2) ◽  
pp. R57 ◽  
Author(s):  
YK Onno Teng ◽  
Gillian Wheater ◽  
Vanessa E Hogan ◽  
Philip Stocks ◽  
EW Nivine Levarht ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
B Cell ◽  
Humoral Immunity ◽  
Cell Depletion ◽  
B Cell Depletion ◽  
Refractory Rheumatoid Arthritis

Biologics registries

2013 ◽  
pp. 257-263
Author(s):  
David Isenberg ◽  
Angela Zink
Keyword(s):  
Rheumatoid Arthritis ◽  
Life Experience ◽  
Real Life ◽  
Cancer Development ◽  
Controlled Trials ◽  
Side Effect Profile ◽  
Risk Of Infection ◽  
Biologic Drugs ◽  
Double Blind

Double-blind controlled trials undertaken over the past two decades have established the short-term effectiveness and side-effect profile of biologic drugs for patients with rheumatoid arthritis and related diseases. However, the development of biologics registers to capture ’real-life experience’ and explore long-term effectiveness and complications is equally important. In this chapter, we demonstrate how these registers have identified long-term joint benefits, a reduction in cardiovascular mortality, reassurance concerning fears about cancer development, and a balanced view of the risk of infection.

scholarly journals Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naïve patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study

2016 ◽  
Vol 76 (1) ◽  
pp. 96-104 ◽  
Author(s):  
P Emery ◽  
C O Bingham ◽  
G R Burmester ◽  
V P Bykerk ◽  
D E Furst ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Prognostic Factors ◽  
Structural Damage ◽  
Certolizumab Pegol ◽  
Health Assessment ◽  
Phase Iii ◽  
Sustained Remission ◽  
Double Blind ◽  
Registration Number ◽  
Modified Total Sharp Score

ObjectivesTo assess the efficacy and safety of certolizumab pegol (CZP)+dose-optimised methotrexate (MTX) versus placebo (PBO)+dose-optimised MTX in inducing and sustaining clinical remission in DMARD-naïve patients with moderate-to-severe, active, progressive rheumatoid arthritis (RA), with poor prognostic factors over 52 weeks.MethodsDMARD-naïve patients with ≤1 year of active RA were randomised (3:1) in a double-blind manner to CZP (400 mg Weeks 0, 2, 4, then 200 mg Q2W to Week 52)+MTX or PBO+MTX (the mean optimised-MTX dose=21 and 22 mg/week, respectively). Sustained remission (sREM) and sustained low disease activity (sLDA; DAS28(ESR)<2.6 and DAS28(ESR)≤3.2, respectively, at both Weeks 40 and 52) were the primary and secondary endpoints.ResultsPatients were randomised to CZP+MTX (n=660) and PBO+MTX (n=219). At Week 52, significantly more patients assigned to CZP+MTX compared with PBO+MTX achieved sREM (28.9% vs 15.0%, p<0.001) and sLDA (43.8% vs 28.6%, p<0.001). Inhibition of radiographic progression and improvements in physical functioning were significantly greater for CZP+MTX versus PBO+MTX (van der Heijde modified total Sharp score (mTSS) mean absolute change from baseline (CFB): 0.2 vs 1.8, p<0.001, rate of mTSS non-progressors: 70.3% vs 49.7%, p<0.001; least squares (LS) mean CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI): −1.00 vs −0.82, p<0.001). Incidence of adverse events (AEs) and serious AEs was similar between treatment groups. Infection was the most frequent AE, with higher incidence for CZP+MTX (71.8/100 patient-years (PY)) versus PBO+MTX (52.7/100 PY); the rate of serious infection was similar between CZP+MTX (3.3/100 PY) and PBO+MTX (3.7/100 PY).ConclusionsCZP+dose-optimised MTX treatment of DMARD-naïve early RA resulted in significantly more patients achieving sREM and sLDA, improved physical function and inhibited structural damage compared with PBO+dose-optimised MTX.Trial registration numberNCT01519791.

scholarly journals Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study

2017 ◽  
Vol 77 (2) ◽  
pp. 234-240 ◽  
Author(s):  
Josef S Smolen ◽  
Jung-Yoon Choe ◽  
Nenad Prodanovic ◽  
Jaroslaw Niebrzydowski ◽  
Ivan Staykov ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Transition Period ◽  
Phase Iii ◽  
Double Blind ◽  
Treatment Groups ◽  
American College Of Rheumatology ◽  
Registration Number ◽  
Phase Iii Study ◽  
Transition Study ◽  
To Receive

ObjectivesEfficacy, safety and immunogenicity results from the phase III study of SB2, a biosimilar of reference infliximab (INF), were previously reported through 54 weeks. This transition period compared results in patients with rheumatoid arthritis (RA) who switched from INF to SB2 with those in patients who maintained treatment with INF or SB2.MethodsPatients with moderate to severe RA despite methotrexate treatment were randomised (1:1) to receive SB2 or INF at weeks 0, 2 and 6 and every 8 weeks thereafter until week 46. At week 54, patients previously receiving INF were rerandomised (1:1) to switch to SB2 (INF/SB2 (n=94)) or to continue on INF (INF/INF (n=101)) up to week 70. Patients previously receiving SB2 continued on SB2 (SB2/SB2 (n=201)) up to week 70. Efficacy, safety and immunogenicity were assessed up to week 78.ResultsEfficacy was sustained and comparable across treatment groups. American College of Rheumatology (ACR) 20 responses between weeks 54 and 78 ranged from 63.5% to 72.3% with INF/SB2, 66.3%%–69.4% with INF/INF and 65.6%–68.3% with SB2/SB2. Treatment-emergent adverse events during this time occurred in 36.2%, 35.6% and 40.3%, respectively, and infusion-related reactions in 3.2%, 2.0% and 3.5%. Among patients who were negative for antidrug antibodies (ADA) up to week 54, newly developed ADAs were reported in 14.6%, 14.9% and 14.1% of the INF/SB2, INF/INF and SB2/SB2 groups, respectively.ConclusionsThe efficacy, safety and immunogenicity profiles remained comparable among the INF/SB2, INF/INF and SB2/SB2 groups up to week 78, with no treatment-emergent issues or clinically relevant immunogenicity after switching from INF to SB2.Trial registration numberNCT01936181; EudraCT number: 2012-005733-37.

scholarly journals Screening for and management of comorbidities after a nurse-led program: results of a 3-year longitudinal study in 769 established rheumatoid arthritis patients

RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e000914 ◽  
Author(s):  
Laure Gossec ◽  
Martin Soubrier ◽  
Frantz Foissac ◽  
Anna Molto ◽  
Pascal Richette ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Wilcoxon Test ◽  
Paired Data ◽  
Registration Number ◽  
The Mean ◽  
Patient Advice ◽  
Randomised Controlled ◽  
Comorbidity Status

Background/purposeCardiovascular (CV) risk, cancer, infections and osteoporosis should be screened for in rheumatoid arthritis (RA). The objective was to assess 3-year effects of a nurse visit for comorbidity counselling.MethodsThis was an open long-term (3 years) extension of the Comorbidities and Education in Rheumatoid Arthritis 6-month randomised controlled trial in which patients with definite, stable RA were visiting a nurse for comorbidity counselling. Comorbidity status was assessed and nurses provided advice on screening and management, at baseline and 3 years later. A score was developed to quantify comorbidity screening and management: 0–100, where lower scores indicate better screening and management. The score was compared between baseline and 3-year assessment using a Wilcoxon test for paired data.ResultsOf the 970 recruited patients, 776 (80%) were followed-up at 2–4 years and 769 (79%) had available data for comorbidities at both time points: mean (±SD) age 58 (±11) years and mean disease duration 14 (±10) years; 614 (80%) were women, the mean Disease Activity Score 28 was 3.0±1.3, and 538 (70%) were receiving a biologic. At baseline, the mean comorbidity screening score was 36.6 (±19.9) and it improved at 3 years to 24.3 (±17.8) (p<0.0001), thus with a relative improvement of 33% (improvement of 12 points). CV risk screening, vaccination status and bone densitometry performance improved the most.ConclusionsComorbidity screening was suboptimal but improved notably over 3 years, after a nurse-led programme aiming at checking systematically for comorbidity screening and giving patient advice. This long-term efficacy pleads in favour of nurse-led interventions to better address comorbidities in RA.Trial registration numberNCT01315652

Sign in / Sign up

Export Citation Format

Share Document