A Phase III randomized, controlled trial of a modified-release hydrocortisone formulation in the treatment of classic congenital adrenal hyperplasia

2020 ◽  
Author(s):  
Deborah Merke ◽  
Ashwini Mallappa ◽  
Wiebke Arlt ◽  
la Perriere Aude Brac de ◽  
Linden Angelica Hirschberg ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Congenital Adrenal Hyperplasia ◽  
Controlled Trial ◽  
Phase Iii ◽  
Modified Release ◽  
Adrenal Hyperplasia ◽  
Randomized Controlled ◽  
Classic Congenital Adrenal Hyperplasia

scholarly journals Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Candidate: A Phase III Randomized Controlled Trial in Children

2013 ◽  
Vol 208 (4) ◽  
pp. 544-553 ◽  
Author(s):  
Joanne M. Langley ◽  
Alfonso Carmona Martinez ◽  
Archana Chatterjee ◽  
Scott A. Halperin ◽  
Shelly McNeil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Influenza Vaccine ◽  
Vaccine Candidate ◽  
Controlled Trial ◽  
Phase Iii ◽  
Randomized Controlled ◽  
Quadrivalent Influenza Vaccine

Prostate-Only Versus Whole-Pelvic Radiation Therapy in High-Risk and Very High-Risk Prostate Cancer (POP-RT): Outcomes From Phase III Randomized Controlled Trial

2021 ◽  
pp. JCO.20.03282
Author(s):  
Vedang Murthy ◽  
Priyamvada Maitre ◽  
Sadhana Kannan ◽  
Gitanjali Panigrahi ◽  
Rahul Krishnatry ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomized Controlled Trial ◽  
High Risk ◽  
Controlled Trial ◽  
Androgen Deprivation ◽  
Phase Iii ◽  
Free Survival ◽  
Randomized Controlled ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer

PURPOSE We report the clinical outcomes of a randomized trial comparing prophylactic whole-pelvic nodal radiotherapy to prostate-only radiotherapy (PORT) in high-risk prostate cancer. METHODS This phase III, single center, randomized controlled trial enrolled eligible patients undergoing radical radiotherapy for node-negative prostate adenocarcinoma, with estimated nodal risk ≥ 20%. Randomization was 1:1 to PORT (68 Gy/25# to prostate) or whole-pelvic radiotherapy (WPRT, 68 Gy/25# to prostate, 50 Gy/25# to pelvic nodes, including common iliac) using computerized stratified block randomization, stratified by Gleason score, type of androgen deprivation, prostate-specific antigen at diagnosis, and prior transurethral resection of the prostate. All patients received image-guided, intensity-modulated radiotherapy and minimum 2 years of androgen deprivation therapy. The primary end point was 5-year biochemical failure-free survival (BFFS), and secondary end points were disease-free survival (DFS) and overall survival (OS). RESULTS From November 2011 to August 2017, a total of 224 patients were randomly assigned (PORT = 114, WPRT = 110). At a median follow-up of 68 months, 36 biochemical failures (PORT = 25, WPRT = 7) and 24 deaths (PORT = 13, WPRT = 11) were recorded. Five-year BFFS was 95.0% (95% CI, 88.4 to 97.9) with WPRT versus 81.2% (95% CI, 71.6 to 87.8) with PORT, with an unadjusted hazard ratio (HR) of 0.23 (95% CI, 0.10 to 0.52; P < .0001). WPRT also showed higher 5-year DFS (89.5% v 77.2%; HR, 0.40; 95% CI, 0.22 to 0.73; P = .002), but 5-year OS did not appear to differ (92.5% v 90.8%; HR, 0.92; 95% CI, 0.41 to 2.05; P = .83). Distant metastasis-free survival was also higher with WPRT (95.9% v 89.2%; HR, 0.35; 95% CI, 0.15 to 0.82; P = .01). Benefit in BFFS and DFS was maintained across prognostic subgroups. CONCLUSION Prophylactic pelvic irradiation for high-risk, locally advanced prostate cancer improved BFFS and DFS as compared with PORT, but OS did not appear to differ.

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
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