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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 22 July 2013
Main ID:  EUCTR2012-004482-40-ES
Date of registration: 16/05/2013
Prospective Registration: Yes
Primary sponsor: FRANCISCO J. BLANCO GARCÍA
Public title: Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapies
Scientific title: Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized.
Date of first enrolment: 18/06/2013
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004482-40
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: guideline standard therapy biological in rheumatoid arthritis Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Spain
Contacts
Name: FRANCISCO J BLANCO   
Address:  XUBIAS DE ARRIBA, Nº 84 15006 A CORUÑA Spain
Telephone: +34981176399
Email: fblagar@sergas.es
Affiliation:  COMPLEJO HOSPITALARIO UNIVERSITARIO A CORUÑA
Name: FRANCISCO J BLANCO   
Address:  XUBIAS DE ARRIBA, Nº 84 15006 A CORUÑA Spain
Telephone: +34981176399
Email: fblagar@sergas.es
Affiliation:  COMPLEJO HOSPITALARIO UNIVERSITARIO A CORUÑA
Key inclusion & exclusion 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 <2.4 or SDAI <3.3) during the last 6 months prior the baseline visit.
? Patients who give their informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Intervention(s)

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
Concentration type: equal
Concentration number: 3-

Trade Name: HUMIRA
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: ENBREL
Product Name: Etanercept
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: CIMZIA
Product Name: Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: SIMPONI
Product Name: Golimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: ORENCIA
Product Name: Abatacept
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 1000-

Trade Name: RoActemra
Product Name: Tocilizumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 8-

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
Concentra
Primary Outcome(s)
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).
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).
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
Timepoint(s) of evaluation of this end point: 12, 24, 36 and 48 weeks
Secondary Outcome(s)
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
Secondary ID(s)
OPTIBIO-2012
Source(s) of Monetary Support
FRANCISCO J. BLANCO GARCIA
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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