Cash transfer during the COVID-19 pandemic: a multicentre, randomised controlled trial

ObjectiveTo evaluate the effect of a one-time cash transfer of $C1000 in people who are unable to physically distance due to insufficient income.DesignOpen-label, multi-centre, randomised superiority trial.SettingSeven primary care sites in Ontario, Canada; six urban sites associated with St. Michael’s Hospital in Toronto and one in Manitoulin Island.Participants392 individuals who reported trouble affording basic necessities due to disruptions related to COVID-19.InterventionAfter random allocation, participants either received the cash transfer of $C1000 (n=196) or physical distancing guidelines alone (n=196).Main outcome measuresThe primary outcome was the maximum number of symptoms consistent with COVID-19 over 14 days. Secondary outcomes were meeting clinical criteria for COVID-19, SARS-CoV-2 presence, number of close contacts, general health and ability to afford basic necessities.ResultsThe primary outcome of number of symptoms reported by participants did not differ between groups after 2 weeks (cash transfer, mean 1.6 vs 1.9, ratio of means 0.83; 95% CI 0.56 to 1.24). There were no statistically significant effects on secondary outcomes of the meeting COVID-19 clinical criteria (7.9% vs 12.8%; risk difference −0.05; 95% CI −0.11 to 0.01), SARS-CoV-2 presence (0.5% vs 0.6%; risk difference 0.00 95% CI −0.02 to 0.02), mean number of close contacts (3.5 vs 3.7; rate ratio 1.10; 95% CI 0.83 to 1.46), general health very good or excellent (60% vs 63%; risk difference −0.03 95% CI −0.14 to 0.08) and ability to make ends meet (52% vs 51%; risk difference 0.01 95% CI −0.10 to 0.12).ConclusionsA single cash transfer did not reduce the COVID-19 symptoms or improve the ability to afford necessities. Further studies are needed to determine whether some groups may benefit from financial supports and to determine if a higher level of support is beneficial.Trial registration numberNCT04359264.

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Hypnotherapy for irritable bowel syndrome-type symptoms in patients with quiescent inflammatory bowel disease: a randomized, controlled trial

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjaa241 ◽

2020 ◽

Author(s):

Daniël R Hoekman ◽

Arine M Vlieger ◽

Pieter C Stokkers ◽

Nofel Mahhmod ◽

Svend Rietdijk ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Irritable Bowel Syndrome ◽

Bowel Disease ◽

Primary Outcome ◽

Controlled Trial ◽

Open Label ◽

Randomized Controlled ◽

Inflammatory Bowel ◽

Secondary Outcomes ◽

Irritable Bowel

Abstract Background and aims Many inflammatory bowel disease (IBD) patients in remission have persisting symptoms, compatible with irritable bowel syndrome (IBS-type symptoms). We aimed to compare the effectiveness of gut-directed hypnotherapy versus standard medical treatment (SMT) for IBS-type symptoms in IBD patients. Methods In this multicenter, randomized, controlled, open label trial, patients aged 12-65 years with IBD in clinical remission (global assessment) and biochemical remission (fecal calprotectin ≤100 µg/g, or ≤200 µg/g without inflammation at endoscopy) with IBS according to Rome III criteria, were randomized to hypnotherapy or SMT. Primary outcome was the proportion with ≥50% reduction on a visual analogue scale for symptom severity, as measured with the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) at week 40 (i.e. 6 months after finishing the intervention), compared to baseline. Secondary outcomes included total IBS-SSS score, quality of life, adequate relief, IBS-related cognitions and depression and anxiety scores. Results Eighty patients were included, of whom 70 received at least one session of the allocated treatment and were included in the modified intention-to-treat-population. Seven patients were excluded because of missing baseline data required for the primary outcome. The primary outcome was met in 9 (27%) of 33 patients randomized to SMT and 9 (30%) of 30 patients randomized to hypnotherapy (p=0.81). Adequate relief was reported in respectively 60% and 40% of subjects. Exploratory analyses of secondary outcomes revealed no apparent differences between both treatment groups. Conclusions Hypnotherapy was not superior to SMT in the treatment of IBS-type symptoms IBD patients. Both treatment strategies are reasonable options from a clinical perspective.

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Seven Versus 14 Days of Antibiotic Therapy for Uncomplicated Gram-negative Bacteremia: A Noninferiority Randomized Controlled Trial

Clinical Infectious Diseases ◽

10.1093/cid/ciy1054 ◽

2018 ◽

Vol 69 (7) ◽

pp. 1091-1098 ◽

Cited By ~ 56

Author(s):

Dafna Yahav ◽

Erica Franceschini ◽

Fidi Koppel ◽

Adi Turjeman ◽

Tanya Babich ◽

...

Keyword(s):

Antibiotic Therapy ◽

Primary Outcome ◽

Controlled Trial ◽

Risk Difference ◽

Open Label ◽

Gram Negative ◽

Short Course ◽

Gram Negative Bacteremia ◽

Focus Of Infection ◽

To Receive

Abstract Background Gram-negative bacteremia is a major cause of morbidity and mortality in hospitalized patients. Data to guide the duration of antibiotic therapy are limited. Methods This was a randomized, multicenter, open-label, noninferiority trial. Inpatients with gram-negative bacteremia, who were afebrile and hemodynamically stable for at least 48 hours, were randomized to receive 7 days (intervention) or 14 days (control) of covering antibiotic therapy. Patients with uncontrolled focus of infection were excluded. The primary outcome at 90 days was a composite of all-cause mortality; relapse, suppurative, or distant complications; and readmission or extended hospitalization (>14 days). The noninferiority margin was set at 10%. Results We included 604 patients (306 intervention, 298 control) between January 2013 and August 2017 in 3 centers in Israel and Italy. The source of the infection was urinary in 411 of 604 patients (68%); causative pathogens were mainly Enterobacteriaceae (543/604 [90%]). A 7-day difference in the median duration of covering antibiotics was achieved. The primary outcome occurred in 140 of 306 patients (45.8%) in the 7-day group vs 144 of 298 (48.3%) in the 14-day group (risk difference, –2.6% [95% confidence interval, –10.5% to 5.3%]). No significant differences were observed in all other outcomes and adverse events, except for a shorter time to return to baseline functional status in the short-course therapy arm. Conclusions In patients hospitalized with gram-negative bacteremia achieving clinical stability before day 7, an antibiotic course of 7 days was noninferior to 14 days. Reducing antibiotic treatment for uncomplicated gram-negative bacteremia to 7 days is an important antibiotic stewardship intervention. Clinical Trials Registration NCT01737320.

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Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-021-01133-8 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Russell Jago ◽

Byron Tibbitts ◽

Kathryn Willis ◽

Emily Sanderson ◽

Rebecca Kandiyali ◽

...

Keyword(s):

Physical Activity ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

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Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

Scientific Reports ◽

10.1038/s41598-021-89444-5 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Manaf AlQahtani ◽

Abdulkarim Abdulrahman ◽

Abdulrahman Almadani ◽

Salman Yousif Alali ◽

Alaa Mahmood Al Zamrooni ◽

...

Keyword(s):

Standard Therapy ◽

Primary Outcome ◽

Controlled Trial ◽

Severe Disease ◽

Pilot Trial ◽

Standard Of Care ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Open Label ◽

Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

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Diclofenac Sodium Gel in Patients with Primary Hand Osteoarthritis: A Randomized, Double-blind, Placebo-controlled Trial

The Journal of Rheumatology ◽

10.3899/jrheum.081316 ◽

2009 ◽

Vol 36 (9) ◽

pp. 1991-1999 ◽

Cited By ~ 78

Author(s):

ROY D. ALTMAN ◽

RENÉE-LILIANE DREISER ◽

CHESTER L. FISHER ◽

WALTER F. CHASE ◽

DONATUS S. DREHER ◽

...

Keyword(s):

Disease Activity ◽

Pain Intensity ◽

Primary Outcome ◽

Controlled Trial ◽

Diclofenac Sodium ◽

Global Rating ◽

Hand Osteoarthritis ◽

Dominant Hand ◽

Double Blind ◽

Secondary Outcomes

Objective.To measure the efficacy and safety of diclofenac sodium gel in patients with primary hand osteoarthritis (OA).Methods.In a randomized, double-blind, placebo-controlled trial, men and women aged ≥ 40 years diagnosed with primary OA in the dominant hand were randomly assigned to self-apply topical 1% diclofenac sodium gel (Voltaren® Gel) (n = 198) or vehicle (n = 187) to both hands 4 times daily for 8 weeks. Primary outcome measures included OA pain intensity (100-mm visual analog scale), total Australian/Canadian Osteoarthritis Hand Index (AUSCAN) score, and global rating of disease activity at 4 and 6 weeks. Secondary outcomes included onset of efficacy in Weeks 1 and 2, durability of efficacy at 8 weeks, measures of disease activity in the dominant hand, pain intensity in the non-dominant hand, AUSCAN subindices, end of study rating of efficacy, and Osteoarthritis Research Society International response criteria.Results.Diclofenac sodium gel decreased pain intensity scores by 42%–45%, total AUSCAN scores by 35%–40%, and global rating of disease by 36%–40%. Significant differences favoring diclofenac sodium gel over vehicle were observed at Week 4 for pain intensity and AUSCAN, with a trend for global rating of disease activity. At Week 6, diclofenac sodium gel treatment significantly improved each primary outcome measure compared with vehicle. Secondary outcomes generally supported the primary outcomes. The most common treatment-related adverse event (AE) was application-site paresthesia. Most AE were mild. No cardiac events, gastrointestinal bleeding, or ulcers were reported.Conclusion.Topical diclofenac sodium gel was generally well tolerated and effective in primary hand OA. (NCT ID: NCT00171665)

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A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

Scientific Reports ◽

10.1038/s41598-021-92242-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Lara Bücker ◽

Josefine Gehlenborg ◽

Steffen Moritz ◽

Stefan Westermann

Keyword(s):

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Primary Outcome ◽

Controlled Trial ◽

Group Differences ◽

Control Group ◽

Gambling Problems ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

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An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial

JMIR Mental Health ◽

10.2196/14648 ◽

2019 ◽

Vol 6 (10) ◽

pp. e14648 ◽

Cited By ~ 9

Author(s):

Peter Johansson ◽

Mats Westas ◽

Gerhard Andersson ◽

Urban Alehagen ◽

Anders Broström ◽

...

Keyword(s):

Cardiovascular Disease ◽

Randomized Controlled Trial ◽

Cognitive Behavioral Therapy ◽

Primary Outcome ◽

Behavioral Therapy ◽

Controlled Trial ◽

Cognitive Behavioral ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Eq Vas

Background Depression is a common cause of reduced well-being and prognosis in patients with cardiovascular disease (CVD). However, there is a lack of effective intervention strategies targeting depression. Objective The study aimed to evaluate the effects of a nurse-delivered and adapted internet-based cognitive behavioral therapy (iCBT) program aimed at reducing depression in patients with CVD. Methods A randomized controlled trial was conducted. A total of 144 patients with CVD with at least mild depression (Patient Health Questionnaire–9 [PHQ-9] score ≥5) were randomized 1:1 to a 9-week program of iCBT (n=72) or an active control participating in a Web-based discussion forum (online discussion forum [ODF], n=72). The iCBT program, which included 7 modules, was adapted to fit patients with CVD. Nurses with an experience of CVD care provided feedback and a short introduction to cognitive behavioral therapy. The primary outcome, depression, was measured using PHQ-9. Secondary outcomes were depression measured using the Montgomery-Åsberg Depression Rating Scale–self-rating version (MADRS-S), health-related quality of life (HRQoL) measured using Short Form 12 (SF-12) survey and EuroQol Visual Analogue Scale (EQ-VAS), and the level of adherence. An intention-to-treat analysis with multiple imputations was used. Between-group differences in the primary and secondary outcomes were determined by the analysis of covariance, and a sensitivity analysis was performed using mixed models. Results Compared with ODF, iCBT had a significant and moderate treatment effect on the primary outcome depression (ie, PHQ-9; mean group difference=−2.34 [95% CI −3.58 to −1.10], P<.001, Cohen d=0.62). In the secondary outcomes, compared with ODF, iCBT had a significant and large effect on depression (ie, MADRS-S; P<.001, Cohen d=0.86) and a significant and moderate effect on the mental component scale of the SF-12 (P<.001, Cohen d=0.66) and the EQ-VAS (P<.001, Cohen d=0.62). Overall, 60% (n=43) of the iCBT group completed all 7 modules, whereas 82% (n=59) completed at least half of the modules. No patients were discontinued from the study owing to a high risk of suicide or deterioration in depression. Conclusions Nurse-delivered iCBT can reduce depression and improve HRQoL in patients with CVD, enabling treatment for depression in their own homes and at their preferred time. Trial Registration ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074

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Efficacy and Safety of Lianhuaqingwen Capsules for the Prevention of Coronavirus Disease 2019: A Prospective Open-Label Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/7962630 ◽

2021 ◽

Vol 2021 ◽

pp. 1-9

Author(s):

Xiaowei Gong ◽

Boyun Yuan ◽

Yadong Yuan ◽

Fengju Li

Keyword(s):

Nucleic Acid ◽

Treatment Group ◽

Close Contact ◽

Controlled Trial ◽

Control Group ◽

Open Label ◽

Medical Observation ◽

Observation Period ◽

Close Contacts ◽

Nucleic Acid Tests

Coronavirus disease 2019 (COVID-19) has become a global pandemic. Community and close contact exposures continue to drive the COVID-19 pandemic. There is no confirmed effective treatment for suspected cases and close contacts. Lianhuaqingwen (LH) capsules, a repurposed Chinese herbal product that is currently on the market, have proven effective for influenza and COVID-19. To determine the safety and efficacy of LH capsules for the prevention of COVID-19, we conducted a prospective open-label controlled trial of LH capsules on subjects who had close contact with people infected with COVID-19. Subjects received LH capsules (4 capsules, three times daily) or the usual medical observation for 14 days. The primary endpoint was the rate of positive nucleic acid tests of nasal and pharyngeal swabs during the quarantine medical observation period. We included 1976 patients, including 1101 in the treatment group and 875 in the control group. The rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.27% vs. 1.14%, respectively; mean difference: −0.87%; 95% CI: −1.83 to −0.13; p = 0.0174 ) during the quarantine medical observation period (14 days). Among subjects with different close contact states, there was no significant difference in the rate of positive nucleic acid test results among close contacts in the treatment group and the control group (6.45% vs. 11.43%, respectively; p = 0.6762 ). Among secondary close contacts, the rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.09% vs. 0.71%, respectively; p = 0.0485 ). No serious adverse events were reported. Taken together, and in light of the safety and effectiveness profiles, these results show that LH capsules can be considered to prevent the progression of COVID-19 after close contact with an infected person. This trial is registered with ChiCTR2100043012.

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The effect of referral for brief intervention for alcohol misuse on repetition of deliberate self-harm: an exploratory randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291709991899 ◽

2010 ◽

Vol 40 (11) ◽

pp. 1821-1828 ◽

Cited By ~ 19

Author(s):

M. J. Crawford ◽

E. Csipke ◽

A. Brown ◽

S. Reid ◽

K. Nilsen ◽

...

Keyword(s):

Alcohol Consumption ◽

Health Information ◽

Brief Intervention ◽

Primary Outcome ◽

Alcohol Misuse ◽

Controlled Trial ◽

Information Leaflet ◽

Deliberate Self Harm ◽

Self Harm ◽

Secondary Outcomes

BackgroundReferral for brief intervention among people who misuse alcohol is reported to be effective but its impact among those who present to services following deliberate self-harm (DSH) has not been examined.MethodConsecutive patients who presented to an Emergency Department (ED) following an episode of DSH were screened for alcohol misuse. Those found to be misusing alcohol were randomly assigned to brief intervention plus a health information leaflet or to a health information leaflet alone. The primary outcome was whether the patient reattended an ED following a further episode of DSH during the subsequent 6 months. Secondary outcomes were alcohol consumption, mental health and satisfaction with care measured 3 and 6 months after randomization.ResultsOne hundred and three people took part in the study. Follow-up data on our primary outcome were obtained for all subjects and on 63% for secondary outcomes. Half those referred for brief intervention received it. Repetition of DSH was strongly associated with baseline alcohol consumption, but not influenced by treatment allocation. There was a non-significant trend towards the number of units of alcohol consumed per drinking day being lower among those randomized to brief intervention.ConclusionsReferral for brief intervention for alcohol misuse following an episode of DSH may not influence the likelihood of repetition of self-harm. Longer-term interventions may be needed to help people who deliberately harm themselves and have evidence of concurrent alcohol misuse.

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An open-label randomized controlled trial of DMARD withdrawal in RA patients achieving therapeutic response with certolizumab pegol combined with DMARDs

Rheumatology ◽

10.1093/rheumatology/kez470 ◽

2019 ◽

Vol 59 (7) ◽

pp. 1522-1528

Author(s):

Janet Pope ◽

Emmanouil Rampakakis ◽

Julie Vaillancourt ◽

Louis Bessette ◽

Juris Lazovskis ◽

...

Keyword(s):

Combination Therapy ◽

Disease Activity ◽

Therapeutic Response ◽

Absolute Risk ◽

Controlled Trial ◽

Certolizumab Pegol ◽

Risk Difference ◽

Inadequate Response ◽

Open Label ◽

Low Disease Activity

Abstract Objectives The objective of this trial was to compare effectiveness of certolizumab pegol added to conventional synthetic DMARDs (csDMARDs) in RA patients, followed by continuing vs discontinuing background csDMARDs after treatment response. Methods Patients with active RA who had certolizumab pegol added to their existing csDMARD regimen due to inadequate response were eligible. At 3 or 6 months, patients who achieved a change (Δ) in DAS28 of ⩾1.2 were randomized to continue combination therapy (COMBO) or withdraw csDMARD therapy (MONO) (unblinded). The primary outcome was non-inferiority of stopping vs continuing csDMARD(s) in terms of maintaining ΔDAS28 ⩾ 1.2 or achieving DAS28 low disease activity at 18 months (non-inferiority margin: 15 percentile units). Results A total of 125 patients were enrolled, 88 randomized to COMBO (n = 43) or MONO (n = 45). No significant differences were observed between groups in baseline age, gender, race, RF status or prior biologics (16% vs 11%). Although the rate of ΔDAS28 ⩾ 1.2 and/or DAS28 low disease activity achievement at 18 months was clinically comparable between the two groups (72% vs 69%), non-inferiority assumptions were not met [absolute risk difference (upper limit of 90% CI): 2.6% (19.1%)]. Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: −2.3 vs −2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28 ⩾ 1.2, and 41% each remission. Conclusion Among RA patients achieving a therapeutic response on combination therapy with certolizumab pegol and csDMARDs, withdrawing csDMARDs was not non-inferior to maintaining csDMARDs but improvements were sustained in both groups at 18 months.

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