Evaluation of a Standardized Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy (REDES-TNF/2012)

Study type

• Study type:
  Clinical trial
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Clinical trials

• Clinical trial randomisation:
  Randomised clinical trial

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB02) infliximab

  infliximab
• Medical condition to be studied:
  Spondyloarthropathy

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  190

Study design details

• Main study objective:
  The purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.
• Outcomes:
  1) Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Rheumatology Society (SER)consensus, after 1 year, not designated as safety issue 2) Proportion of patients who are kept in acceptable therapeutic objective according SER consensus (BASDAI < 4, globaclinical impression by physician <4, by patient < 4 and axial nocturnal pain <4) after 1 year. 1) Proportion of patients in remission one year after inclusion in the study, not as safety issue2) Proportion of patients in remission, defined as ASDAS-C score <1.3, after 1 year from inclusion 3) Proportion of patients who experience a clinical reactivation (up to 3 years or December 2014) And other 8 secondary outcomes.
• Data analysis plan:
  Study main objective of non-inferiority will be assessed by estimating the between treatment difference rate (95% confidence interval (95%CI)) and, checking it against the pre-defined non-inferiority margin of 17%. Rates will be estimated using a log-binomial regression model including the treatment and the stratification factor. In the unexpected event that the model does not fit, the Poisson link distribution function will be used instead. A sensibility analysis will be conducted using the Mantel-Haenzel method. Time to decompensation will be estimated by the Kaplan-Meier approach and treatments will be compared with the stratified log-rank test, Cox regression models will be used to estimate Hazard Risks and 95%CI. Rest of variables will be compared depending on type of variables: the Fisher’s exact text for nominal variables, for quantitative variables with Gaussian distribution, the Student's t-test, and for ordinal and continuous non Gaussian variables, the Mann-Whitney test.

Documents

Study, other information

DSMB REDES