scholarly journals Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial

2015 ◽  
Vol 75 (6) ◽  
pp. 1081-1091 ◽  
Author(s):  
Gerd R Burmester ◽  
William F Rigby ◽  
Ronald F van Vollenhoven ◽  
Jonathan Kay ◽  
Andrea Rubbert-Roth ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Physical Function ◽  
Controlled Trial ◽  
Health Assessment ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Treatment Groups ◽  
Randomised Controlled

ObjectivesThe efficacy of tocilizumab (TCZ), an anti-interleukin-6 receptor antibody, has not previously been evaluated in a population consisting exclusively of patients with early rheumatoid arthritis (RA).MethodsIn a double-blind randomised controlled trial (FUNCTION), 1162 methotrexate (MTX)-naive patients with early progressive RA were randomly assigned (1:1:1:1) to one of four treatment groups: 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo and placebo+MTX (comparator group). The primary outcome was remission according to Disease Activity Score using 28 joints (DAS28–erythrocyte sedimentation rate (ESR) <2.6) at week 24. Radiographic and physical function outcomes were also evaluated. We report results through week 52.ResultsThe intent-to-treat population included 1157 patients. Significantly more patients receiving 8 mg/kg TCZ+MTX and 8 mg/kg TCZ+placebo than receiving placebo+MTX achieved DAS28-ESR remission at week 24 (45% and 39% vs 15%; p<0.0001). The 8 mg/kg TCZ+MTX group also achieved significantly greater improvement in radiographic disease progression and physical function at week 52 than did patients treated with placebo+MTX (mean change from baseline in van der Heijde–modified total Sharp score, 0.08 vs 1.14 (p=0.0001); mean reduction in Health Assessment Disability Index, −0.81 vs −0.64 (p=0.0024)). In addition, the 8 mg/kg TCZ+placebo and 4 mg/kg TCZ+MTX groups demonstrated clinical efficacy that was at least as effective as MTX for these key secondary endpoints. Serious adverse events were similar among treatment groups. Adverse events resulting in premature withdrawal occurred in 20% of patients in the 8 mg/kg TCZ+MTX group.ConclusionsTCZ is effective in combination with MTX and as monotherapy for the treatment of patients with early RA.Trial registration numberClinicalTrials.gov, number NCT01007435

Efficacy of a carrageenan gel in preventing anal human papillomavirus (HPV) infection: interim analysis of the Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV) randomised controlled trial

2021 ◽  
pp. sextrans-2021-055009
Author(s):  
Cassandra Laurie ◽  
Mariam El-Zein ◽  
Joseph E Tota ◽  
Farzin Khosrow-Khavar ◽  
Pierre-Paul Tellier ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Interim Analysis ◽  
Controlled Trial ◽  
Hpv Infection ◽  
Gelling Agent ◽  
Receptive Anal Intercourse ◽  
Double Blind ◽  
Randomised Controlled

BackgroundCarrageenan, a non-toxic gelling agent derived from red algae, has potent anti-human papillomavirus (HPV) activity in in vitro and animal studies. We assessed, in an interim analysis, the efficacy of a carrageenan-based gel in reducing the risk of new detections of anal HPV among gay, bisexual and other men who have sex with men (gbMSM).MethodsThe LIMIT-HPV study (Lubricant Investigation in Men to Inhibit Transmission of HPV Infection) is a phase IIb, double-blind, placebo-controlled randomised controlled trial conducted in Montreal, Canada. gbMSM were randomly assigned (1:1) to receive a carrageenan-based or placebo gel. Participants were instructed to apply the gel to the anus, condom and/or partners’ penis before and—as required—during receptive anal intercourse. Questionnaire data and anal samples were collected at 0, 1, 2, 3, 6, 9 and 12 months. We estimated new detections of anal HPV infection(s) detected via Linear Array using Cox proportional hazards models.ResultsParticipants recruited from February 2016 to December 2019 were randomly assigned to the carrageenan (n=127) or placebo (n=128) arm. The efficacy and safety analyses included 201 and 210 participants. The median follow-up time was 7.6 months (range: 0–28.5) in the carrageenan group and 9.3 months (range: 0–40.7) in the placebo group. The HR for new detections was 1.21 (95% CI 0.86 to 1.70): 69.4% and 65.1% new detections of HPV in the carrageenan and placebo arms, respectively. More adverse events were reported in the carrageenan (59.8%) compared with the placebo (39.8%) arm.ConclusionsThe interim analysis did not demonstrate a protective effect of carrageenan on the risk of new detections of anal HPV infection among gbMSM. Carrageenan gel use was associated with a higher proportion of adverse events. Given these findings and the (assumed) low probability that a beneficial effect would be found by the study’s end, the trial was terminated as recommended by the Data Safety and Monitoring Board.Trial registration numberNCT02354144.

scholarly journals The Effects of Two Maternal Vitamin A Supplementation Regimens on Serum Retinol in Postpartum Mothers: A Randomised Controlled Trial in Brazil

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Luciana Marques Andreto ◽  
Ilma Kruze Grande de Arruda ◽  
Ariani Impieri Souza ◽  
José Natal Figueiroa ◽  
Alcides da Silva Diniz
Keyword(s):  
Randomised Controlled Trial ◽  
Vitamin A ◽  
Vitamin A Deficiency ◽  
Controlled Trial ◽  
Serum Retinol ◽  
Double Blind ◽  
Vitamin A Supplementation ◽  
Treatment Groups ◽  
Randomised Controlled ◽  
Postpartum Mothers

Objective. To test whether the serum retinol level in mothers supplemented with 400,000 IU of vitamin A is higher than in those supplemented with 200,000 IU and to estimate duration of the protective effect of vitamin A supplementation in the serum retinol level. Methods. Double-blind, randomised controlled trial performed in two hospitals in the state of Pernambuco in northeast Brazil. Three hundred twelve mothers were recruited immediately postpartum. All women received a capsule containing 200,000 IU of vitamin A, and 10 days after delivery, they were randomly assigned to one of two treatment groups. One group received a second capsule containing vitamin A and the other group received a placebo. Each group was invited back after 2, 4, and 6 months for serum retinol analyses. Results. No difference was found between the two groups in serum maternal retinol concentration at 2 months (2.13 versus 2.03 μmol/L), 4 months (2.20 versus 2.24 μmol/L) or 6 months (2.29 versus 2.31 μmol/L). Because there was no further effect and because this population has a level of vitamin A deficiency considered mild, our results do not support a proposal to increase the dosing schedule for vitamin A in postpartum women as recommended by the IVACG.

Randomised controlled trial of escitalopram for cervical dystonia with dystonic jerks/tremor

2018 ◽  
Vol 89 (6) ◽  
pp. 579-585 ◽  
Author(s):  
Evelien Zoons ◽  
Jan Booij ◽  
Catherine C S Delnooz ◽  
Joke M Dijk ◽  
Yasmine E M Dreissen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cervical Dystonia ◽  
Rating Scales ◽  
Psychiatric Symptoms ◽  
Controlled Trial ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTrials for additional or alternative treatments for cervical dystonia (CD) are scarce since the introduction of botulinum neurotoxin (BoNT). We performed the first trial to investigate whether dystonic jerks/tremor in patients with CD respond to the selective serotonin reuptake inhibitor (SSRI) escitalopram.MethodsIn a randomised, double-blind, crossover trial, patients with CD received escitalopram and placebo for 6 weeks. Treatment with BoNT was continued, and scores on rating scales regarding dystonia, psychiatric symptoms and quality of life (QoL) were compared. Primary endpoint was the proportion of patients that improved at least one point on the Clinical Global Impression Scale for jerks/tremor scored by independent physicians with experience in movement disorders.ResultsFifty-threepatients were included. In the escitalopram period, 14/49 patients (29%) improved on severity of jerks/tremor versus 11/48 patients (23%) in the placebo period (P=0.77). There were no significant differences between baseline and after treatment with escitalopram or placebo on severity of dystonia or jerks/tremor. Psychiatric symptoms and QoL improved significantly in both periods compared with baseline. There were no significant differences between treatment with escitalopram and placebo for dystonia, psychiatric or QoL rating scales. During treatment with escitalopram, patients experienced slightly more adverse events, but no serious adverse events occurred.ConclusionIn this innovative trial, no add-on effect of escitalopram for treatment of CD with jerks was found on motor or psychiatric symptoms. However, we also did not find a reason to withhold patients treatment with SSRIs for depression and anxiety, which are common in dystonia.Trial registration numberNTR2178.

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