scholarly journals AB0545 COMPARISON BETWEEN METHOTREXATE AND APREMILAST IN PSORIATIC ARTHRITIS-A SINGLE BLINDED RANDOMIZED CONTROLLED TRIAL (APREMEPsA STUDY)

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1305-1306
Author(s):  
J. Samanta ◽  
G. Naidu ◽  
A. Chattopadhyay ◽  
A. Basnet ◽  
T. Narang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Controlled Trial ◽  
Joint Disease ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Significant Difference

Background:Both methotrexate and apremilast were found to be effective in controlling joint disease in psoriatic arthritis (PsA) patients [1-4]. However, there are no head-to-head trials comparing the efficacy of these two drugs in PsA.Objectives:Primary outcome measure was rate of major cDAPSA response (>85% change in cDAPSA score from baseline) at week 24 and secondary outcome measures were ACR 20 response, change in Psoriasis Area and Severity Index (PASI), Maastricht enthesitis score, Leeds dactylitis index, and health assessment questionnaire-disability index (HAQ-DI) and number of adverse events at week 24 between methotrexate and apremilast groups.Methods:Single blinded (physician), parallel group, randomized controlled trial was conducted at a single centre in India between October 2019 and December 2020. Adult PsA patients (age>18 years), fulfilling CASPAR criteria, not receiving methotrexate/apremilast in last 3 months and never receiving bDMARDs or, JAK inhibitors, having active articular disease (one or more swollen joint or, having one or more tender entheseal point) were recruited in this study.Results:A total of 31 patients were recruited (15 in apremilast arm and 16 in methotrexate arm) amongst whom 26 patients completed 24 weeks follow up (13 patients in apremilast arm and 13 patients in methotrexate arm). At baseline, median (IQR) swollen joints were 2 (1) in apremilast group and 2.5 (4) in methotrexate group. Median cDAPSA score at baseline was 23 (9) in apremilast group and 20 (21) in methotrexate group. Major cDAPSA response at week 24 was achieved in three (20%) subjects in apremilast arm and six (37.5%) subjects in methotrexate arm (p=0.433). Seven (46.67%) subjects in apremilast group and nine (56.25%) subjects in methotrexate group achieved ACR 20 response at 24-weeks (p=0.724). The change of PASI score from baseline was significant in apremilast group (2.0, p=0.003) and methotrexate group (0.35, p=0.003), but when compared between the two groups, there was no significant difference(p=0.378). Change in enthesitis score was not significant in both the groups (0.0 in apremilast group, p=0.285; 0.0 in methotrexate group, p=1.0). The median change in dactylitis score [0.0 (9.1), p=0.028] and HAQ-DI score (0.33, p=0.01) were significant in methotrexate group only. However, when compared to the change in apremilast group, the difference was not significant for both the parameters. A total of 9 minor adverse events, 3 with apremilast and 6 with methotrexate, were observed with transaminitis (number of events) being the commonest event noted with methotrexate. There were no serious adverse events noted in either of the groups.Conclusion:There was no significant difference between methotrexate and apremilast in terms of efficacy as measured by cDAPSA and ACR20 responses. Both the drugs were well tolerated by the study population. A larger study with head-to-head comparison between methotrexate and apremilast is needed to conform these findings.References:[1]Baranauskaite A, Raffayová H, Kungurov NV, et al; RESPOND investigators. Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study Ann Rheum Dis. 2012;71:541-8.[2]Mease PJ, Gladman DD, Collier DH, et al. Etanercept and Methotrexate as Monotherapy or in Combination for Psoriatic Arthritis: Primary Results From a Randomized, Controlled Phase III Trial. Arthritis Rheumatol 2019;71:1112-24.[3]Gladman DD, Kavanaugh A, Gómez-Reino JJ, et al. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018;4(1):e000669.[4]Wells AF, Edwards CJ, Kivitz AJ, et al. Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: results of the randomized, placebo-controlled PALACE 4 trial. Rheumatology (Oxford) 2018;57:1253-63.Disclosure of Interests:None declared.

scholarly journals Efficacy of a U-Shaped Automatic Electric Toothbrush in Dental Plaque Removal: A Cross-Over Randomized Controlled Trial

2020 ◽  
Vol 17 (13) ◽  
pp. 4649
Author(s):  
Michele Nieri ◽  
Veronica Giuntini ◽  
Umberto Pagliaro ◽  
Monica Giani ◽  
Lorenzo Franchi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Dental Plaque ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Outcome Variable ◽  
Plaque Score ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Electric Toothbrush

Background: The aim of this single-use, four-treatment, four-period (visit), cross-over, mono-centered, examiner-blind, cross-over randomized controlled trial (RCT) was to evaluate the efficacy in dental plaque removal of a U-shaped automatic electric toothbrush (U) compared to a conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N). Methods: Eligible participants were volunteer students. Primary outcome measure was the reduction in full-mouth plaque score (FMPS) after brushing. The secondary outcome variable was a visual analogic scale (VAS) on subjective clean mouth sensation. Mixed models were performed for difference in FMPS and VAS. Results: Twenty-two participants were randomized to the treatments in the four periods of the study. The differences between treatments in FMPS reduction after brushing were statistically significant (p < 0.0001). The differences were statistically significant between the U and P groups (difference −48; 95% CI from −54 to −41) favoring the P group, and between the U and H groups (difference −45; 95% CI from −52 to −39) favoring the H group. On the contrary, the difference between the U and N groups was not significant (difference 5; 95% CI from −2 to 12) favoring the U group. The differences between treatments in clean mouth VAS was statistically significant (p < 0.0001) favoring the P and H groups. Conclusions: The U-shaped automatic electric toothbrush tested in this study proved to be not effective in removing dental plaque.

scholarly journals Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis

2020 ◽  
Vol 40 (7) ◽  
pp. 1021-1028 ◽  
Author(s):  
Philip J. Mease ◽  
Iain B. McInnes ◽  
Vibeke Strand ◽  
Oliver FitzGerald ◽  
Harris A. Ahmad ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Prognostic Factors ◽  
Psoriatic Arthritis ◽  
Controlled Trial ◽  
Phase Iii ◽  
Randomized Controlled

Efficacy of a step-down regimen of oral prednisolone in axial spondyloarthritis: result of a double-blind randomized controlled trial (COBRA-AS Study)

Rheumatology ◽  
2020 ◽  
Author(s):  
Debashish Mishra ◽  
Varun Dhir ◽  
G S R S N K Naidu ◽  
Aastha Khullar ◽  
Vishal Kumar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Oral Prednisolone ◽  
Functional Improvement ◽  
Inadequate Response ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Step Down

Abstract Objectives To evaluate the efficacy and safety of a step-down regimen of oral prednisolone over 24 weeks in patients of axial SpA (axSpA). Methods This proof-of-concept double-blind randomized controlled trial enrolled patients with active axSpA (BASDAI ≥4) having predominantly axial disease (≤1 active joint currently) and inadequate response to NSAIDs. They were randomized to receive either oral prednisolone (n = 32) or placebo (n = 33) at a dose of 60, 40, 30, 20, 15 and 10 mg daily for 1 week each, following which they received 5 mg prednisolone (or placebo) daily for 18 weeks. The primary endpoint was a 50% improvement in the BASDAI (BASDAI50) at week 24. Analysis was intention to treat. Results A BASDAI50 was achieved by 12 of 32 patients (37.5%) in the prednisolone arm and 3 of 33 patients (9.1%) in the placebo arm at 24 weeks [difference 28.4% (95% CI 7.9, 46.7)]. However, there was no difference in achieving a 20 or 40% improvement in the Assessment of SpondyloArthritis international Society response between the groups. Although there was a significant intergroup difference in adjusted ΔBASDAI and ΔAnkylosing Spondylitis Disease Activity Score with CRP at 24 weeks, there was no difference at 12 weeks. There was also no significant difference in ΔBASFI, ΔBAS-G or ΔBASMI at 12 or 24 weeks. No serious adverse events were noted. There was significant weight gain in the first 12 weeks in the prednisolone group vs placebo [0.9 (s.d. 0.4) kg], but not at 24 weeks. Conclusions In this small study, oral prednisolone was efficacious in axSpA in achieving the primary outcome, but many crucial secondary outcomes such as functional improvement were not met. Its impact on bone loss was not studied. Trial registration: CTRI/2018/01/011342.

scholarly journals Randomized Controlled Trial of Probiotic PS128 in Children with Tourette Syndrome

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 3698
Author(s):  
Chang-Chun Wu ◽  
Lee-Chin Wong ◽  
Chia-Jui Hsu ◽  
Chianne-Wen Yang ◽  
Ying-Chieh Tsai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Tourette Syndrome ◽  
Performance Test ◽  
Controlled Trial ◽  
Continuous Performance Test ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Social Environmental

Tourette syndrome results from a complex interaction between social–environmental factors, multiple genetic abnormalities, and neurotransmitter disturbances. This study is a double-blinded, randomized controlled trial using probiotics Lactobacillus plantarum PS128 as an intervention to examine if probiotics improve symptoms of children with Tourette syndrome. This study enrolled children aged 5 to 18 years old who fulfilled DSM-V diagnostic criteria for Tourette syndrome. Patients were assessed before initiating the trial, at one month, and at two months after randomization. The primary outcome was evaluated by Yale Global Tic Severity Scale (YGTSS), and the secondary outcome studied the possible comorbidities in these children. The results revealed no significant difference in improvement in YGTSS between the control group and the PS128 group. As for secondary endpoints, an analysis of Conners’ Continuous Performance Test (CPT) showed improvement in commission and detectability in the PS128 group. In conclusion, although probiotics may not have tic-reducing effects in children with Tourette syndrome, it may have benefits on comorbidities such as attention deficit and hyperactivity disorder (ADHD). Further studies are needed to clarify the effects of probiotics on the comorbidities of Tourette syndrome children.

scholarly journals The DRESS trial: a feasibility randomized controlled trial of a neuropsychological approach to dressing therapy for stroke inpatients

2011 ◽  
Vol 26 (8) ◽  
pp. 675-685 ◽  
Author(s):  
Marion F Walker ◽  
Alan Sunderland ◽  
Joanna Fletcher-Smith ◽  
Avril Drummond ◽  
Pip Logan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Right Hemisphere ◽  
Controlled Trial ◽  
Phase Iii ◽  
Rehabilitation Service ◽  
Control Group ◽  
Cognitive Difficulties ◽  
Randomized Controlled ◽  
Right Hemisphere Damage ◽  
Significant Difference

Objective: To investigate two approaches to treating patients with persistent dressing problems and cognitive difficulties following stroke. Design: Pilot randomized controlled trial. Setting: Inpatient stroke rehabilitation service. Subjects: Seventy consecutive stroke patients with persistent dressing problems and accompanying cognitive difficulties at two weeks after their stroke. Interventions: Patients were randomly allocated to six weeks of either a systematic neuropsychological approach, based on analysis of dressing problems and further cognitive testing, or to the control group who received conventional (functional) dressing practice. Both groups received treatment three times a week in accordance with two separately prepared manuals. Main measures: Nottingham Stroke Dressing Assessment (NSDA), Line Cancellation, 10-hole peg transfer test, Object Decision, Gesture Imitation. Patients were assessed at six weeks after randomization by an independent assessor masked to group allocation. Results: Both neuropsychological and functional groups improved performance on the NSDA over the treatment period (31% and 22%, respectively) but there was no significant difference between groups at six weeks. However, the neuropsychological group showed a significantly greater improvement on a line cancellation test of visual neglect ( t(62) = 2.1, P < 0.05) and a planned subanalysis for those with right hemisphere damage showed a trend towards better dressing outcome ( P = 0.07, one-tailed). Conclusions: Results demonstrate the potential benefits of a systematic neuropsychological approach to dressing therapy, particularly for patients with right hemisphere damage. This study suggests the need for a phase III study evaluating the efficacy of a systematic neuropsychological approach in treating dressing difficulties, targeting patients with right hemisphere stroke and visuospatial impairments.

scholarly journals Role of suppression of endometriosis with progestins before IVF-ET: a non-inferiority randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eissa Khalifa ◽  
Hashem Mohammad ◽  
Ameer Abdullah ◽  
Mazen Abdel-Rasheed ◽  
Mohammed Khairy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnancy Outcomes ◽  
Ovarian Stimulation ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Cost Of Treatment ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Long Protocol

Abstract Background Endometriosis affects the responsiveness to ovarian stimulation. This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment. Methods In this randomized controlled trial, 134 women with endometriosis-related infertility were randomly allocated to group A (n = 67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol), and Group B (n = 67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF. The primary outcome measure was the number of oocytes retrieved. The secondary outcome measures included the number of mature oocytes, fertilization rate, quality of life assessed by FertiQoL scores, cost of treatment, and pregnancy outcomes. Results Although there was no statistically significant difference between both groups regarding ovarian stimulation, response parameters, and pregnancy outcomes, the Dienogest group had a lower cost of treatment (2773 vs. 3664 EGP, P < 0.001), lower side effects (29.9% vs. 59.7%, P < 0.001), higher FertiQoL treatment scores (33.2 vs. 25.1, P < 0.001) and higher tolerability scores (14.1 vs. 9.4, P < 0.001 < 0.001). Conclusion Our study indicates that Dienogest is a suitable and safe substitute for GnRHa pretreatment in endometriosis patients. Trial registration NCT04500743 “Retrospectively registered on August 5, 2020”.

scholarly journals Radiofrequency Microdebridement as an Adjunct to Arthroscopic Surgical Treatment for Recalcitrant Gluteal Tendinopathy: A Double-Blind, Randomized Controlled Trial

2020 ◽  
Vol 8 (1) ◽  
pp. 232596711989560 ◽  
Author(s):  
Caroline M. Blakey ◽  
John O’Donnell ◽  
Ianiv Klaber ◽  
Parminder Singh ◽  
Manit Arora ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Short Form ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Harris Hip Score ◽  
Secondary Outcome ◽  
Iliotibial Band ◽  
Randomized Controlled ◽  
Gluteal Tendinopathy ◽  
Significant Difference

Background: Recalcitrant greater trochanteric pain is increasingly recognized as an indication for surgical intervention. The arthroscopic approach has become rapidly more common than the open alternative. Hypothesis: Patients undergoing radiofrequency microdebridement (RFMD) as an adjunct to arthroscopic gluteal bursectomy (AGB) and iliotibial band release (ITBR) will experience better functional improvement than AGB and ITBR alone at 1 year. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A total of 33 patients with failed nonoperative treatment of gluteal tendinopathy were randomly allocated to undergo AGB/ITBR or AGB/ITBR + RFMD. Full-thickness tears were excluded. The primary outcome measure was the modified Harris Hip Score (mHHS) at 52 weeks. Secondary outcome measures included the mHHS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analog scale (VAS) for pain, and 12-item Short Form Health Survey (SF-12), which were evaluated at 0, 6, 12, 24, and 52 weeks. Statistical significance was defined as P < .05. Results: A total of 33 participants (33 hips; 30 female and 3 male; mean age, 58 years) were randomized; 16 patients underwent AGB/ITBR + RFMD, and 17 underwent AGB/ITBR. Participants’ functionality improved in both groups at all time intervals. The mean mHHS score improved from 57.49 ± 10.61 to 77.76 ± 18.40 ( P = .004) and from 58.98 ± 12.33 to 79.96 ± 18.86 ( P = .001) at 52 weeks in the AGB/ITBR and AGB/ITBR + RFMD groups, respectively, although there was no statistically significant difference between groups. There were no device-related adverse events. Conclusion: AGB/ITBR led to significant improvements in patients with recalcitrant gluteal tendinopathy. In this small RCT, the addition of RFMD showed no additional benefit to AGB/ITBR but provided a safe adjunct for the surgical management of recalcitrant gluteal tendinopathy. Registration: NCT01562366 ( ClinicalTrials.gov identifier).

Platelet-Rich Plasma for Patellar Tendinopathy: A Randomized Controlled Trial of Leukocyte-Rich PRP or Leukocyte-Poor PRP Versus Saline

2019 ◽  
Vol 47 (7) ◽  
pp. 1654-1661 ◽  
Author(s):  
Alex Scott ◽  
Robert F. LaPrade ◽  
Kimberly G. Harmon ◽  
Giuseppe Filardo ◽  
Elizaveta Kon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Patellar Tendinopathy ◽  
Secondary Outcome ◽  
Global Rating ◽  
Ultrasound Guided ◽  
Randomized Controlled ◽  
Significant Difference

Background: A small number of randomized controlled trials have found ultrasound-guided injection of platelet-rich plasma (PRP) to be no more effective than saline for several tendinopathies; limited information exists for patellar tendinopathy. In addition, different PRP formulations that produce varying concentrations of leukocytes have not been directly compared for patellar tendinopathy. Purpose/Hypothesis: To determine if a single ultrasound-guided PRP injection, either leukocyte-rich PRP (LR-PRP) or leukocyte-poor PRP (LP-PRP), was superior to saline injection for the treatment of patellar tendinopathy. The null hypothesis was that no treatment would be superior to another for the treatment of patellar tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Athletes with patellar tendinopathy for ≥6 months (Blazina stage IIIB) were assessed for eligibility in a multisite single-blind controlled trial. There were 3 injection arms: LR-PRP, LP-PRP, and saline. Patients received a single ultrasound-guided injection, followed by 6 weeks of supervised rehabilitation (heavy slow resistance training, concentric and eccentric, 3 times per week). Outcome measures—Victorian Institute of Sport Assessment (patellar; VISA-P), pain during activity, and global rating of change—were assessed at 6 and 12 weeks and 6 and 12 months. VISA-P score at 12 weeks was the primary outcome. Fifty-seven patients (19 in each group) were included in an intention-to-treat analysis. Secondary outcome measures included pain during activity and patients’ global rating of change. Results: Study retention was 93% at 12 weeks and 79% after 1 year. There was no significant difference in mean change in VISA-P score, pain, or global rating of change among the 3 treatment groups at 12 weeks or any other time point. After 1 year, the mean (SD) outcomes for the LR-PRP, LP-PRP, and saline groups were as follows, respectively: VISA-P—58 (29), 71 (20), and 80 (18); pain—4.0 (2.4), 2.4 (2.3), and 2.0 (1.9); global rating of change—4.7 (1.6), 5.6 (1.0), and 5.7 (1.2) ( P > .05 for all outcomes). Conclusion: Combined with an exercise-based rehabilitation program, a single injection of LR-PRP or LP-PRP was no more effective than saline for the improvement of patellar tendinopathy symptoms. Registration: NCT02116946 (ClinicalTrials.gov identifier).

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