Continuing versus tapering glucocorticoids after achievement of low disease activity or remission in rheumatoid arthritis (SEMIRA): a double-blind, multicentre, randomised controlled trial

The Lancet ◽  
2020 ◽  
Vol 396 (10246) ◽  
pp. 267-276 ◽  
Author(s):  
Gerd R Burmester ◽  
Frank Buttgereit ◽  
Corrado Bernasconi ◽  
Jose M Álvaro-Gracia ◽  
Nidia Castro ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomised Controlled Trial ◽  
Disease Activity ◽  
Controlled Trial ◽  
Double Blind ◽  
Low Disease Activity ◽  
Randomised Controlled

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

scholarly journals Effect of nurse-led care on outcomes in patients with ACPA/RF-positive rheumatoid arthritis with active disease undergoing treat-to-target: a multicentre randomised controlled trial

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001627
Author(s):  
Juliana Rachel Hoeper ◽  
Jan Zeidler ◽  
Sara Eileen Meyer ◽  
Georg Gauler ◽  
Patricia Steffens-Korbanka ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Randomised Controlled Trial ◽  
Disease Activity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Demographic Data ◽  
Clinical Effectiveness ◽  
Treat To Target ◽  
Randomised Controlled ◽  
Active Disease

ObjectiveTo determine the non-inferiority of nurse-led care (NLC) in patients with anticitrullinated protein antibody (ACPA)-positive and/or rheumatoid factor (RF)-positive rheumatoid arthritis (RA) with active disease who are starting disease-modifying antirheumatic drug therapy, following treat-to-target (T2T) recommendations.MethodsA multicentre, pragmatic randomised controlled trial was conducted to assess clinical effectiveness, anxiety, depression and patient satisfaction following a non-inferiority design. The participants were 224 adults with ACPA/RF-positive RA who were randomly assigned to either NLC or rheumatologist-led care (RLC). The primary outcome was the Disease Activity Score in 28 Joints measured with C reactive protein (DAS28-CRP) assessed at baseline and after 3, 6, 9 and 12 months. A DAS28-CRP difference of 0.6 was set as the non-inferiority margin. Mean differences between the groups were assessed following per-protocol and intention-to-treat strategies.ResultsDemographic data and baseline characteristics of patients in the NLC group (n=111) were comparable to those of patients in the RLC group (n=113). The improvement in disease activity (change in DAS28-CRP, primary outcome) over the course of 12 months was significant in both groups (p<0.001). No significant differences were observed between the NLC and RLC groups (p=0.317). Non-inferiority of NLC was shown for the primary outcome and all secondary outcomes.ConclusionThis study supported the non-inferiority of NLC in managing T2T and follow-up care of patients with RA with moderate to high disease activity and poor prognostic factors in addition to RLC.Trial registration numberDRKS00013055.

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