Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies
Conditions
Interventions
Product Name: Infliximab
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentrati
Sponsors
FRANCISCO J. BLANCO GARCÍA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients over 18 years. ? Patients with rheumatoid arthritis (RA) according to the classification of the 1987 ACR criteria. ? Patients treated with biologic therapy (infliximab, adalimumab, etanercept, golimumab, certolizumab, abatacept, rituximab, tocilizumab) showing an established clinical remission. ? Patients who are in remission (defined by a DAS28 =65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: ? Patients with RA and clinic predominantly systemic manifestations to which biological therapy on the occasion of such systemic manifestations have been instructed. ? Patients with AR and any associated pathology known that interfere with or modify the clinical evaluation of the patient (fibromyalgia or association to another chronic inflammatory disease). ? Patients in chronic treatment with biologic therapy that are already in some patterns of reduction which will be studied in the experimental group, or guidelines of dose lower or more spaced than the of the experimental group, prior to inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Check in patients with RA who have clinical remission under treatment with a biologic therapy, the proportion of patients that after 1 year stay in remission (DAS28 <2.4 or SDAI <3.3 or ACR/EULAR criteria) with a pattern of decreasing doses of biological therapy; and check if the proportion of patients with the new pattern of treatment is not less than that observed with the pattern of standard treatment (according to technical specifications and consensus be of biological therapy in AR).;Secondary Objective: Check if the proportion of patients that remains in the ideal therapeutic target (DAS28 <2.4 or SDAI <3.3 or ACR/EULAR criteria) after 2 years with the pattern of decrease in dose of biological therapy is not less with respect to the standard ? Compare the effectiveness of the pattern of decrease in dose with the pattern of standard treatment in terms of clinical manifestations or activity; function or physical ability; assessment of the needs of analgesic, treatment steroid I NSAID; analysis of the time until the end of participation in the study because of treatment failure and quality of life ? Compare the security between the two therapeutic strategies ? Compare the direct costs between the two therapies guidelines ? Explore possible (clinical and biological) factors involved in the therapeutic response ? Explore differences in the progression of structural damage between the two treatment groups;Primary end point(s): Proportion of patients 1 year after maintained in the ideal therapeutic target according to consensus being, understood as remission (DAS28 <2.4 or SDAI <3.3 or EULAR/ACR criteria).;Timepoint(s) of evaluation of this end point: 12, 24, 36 and 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients that after 2 years stay in the ideal therapeutic target according to consensus being, understood as remission (DAS28 <2.4 or SDAI <3.3 or EULAR/ACR criteria).;Timepoint(s) of evaluation of this end point: Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 | — |
Countries
Spain
Contacts
Public ContactFRANCISCO J BLANCO
COMPLEJO HOSPITALARIO UNIVERSITARIO A CORUÑA
Outcome results
None listed