Clinical trial NCT01078571: Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis
Official title: Safety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Biologic
Tumor Necrosis Factors blockers agents Monoclonal antibody
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 705
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatologist consultant

Brief summary: Adalimumab is one of the pharmacological treatments for rheumatoid arthritis (RA) of more recent marketing authorization, and as a result of this, there are only efficacy and safety data from clinical trials with controlled conditions.The study will evaluate the safety and effectiveness of adalimumab in the common clinical practice of RA treatment in Spain, with several types of patients showing concomitant treatments or diseases and compliance. Among the tumor necrosis factor antagonists safety studies, adalimumab safety has been the less investigated in the common clinical practice because of, as a result of its recent marketing, it was not included in the BIOBADASER (Data Base for Biological Products in Spain, Rheumatology Spanish Society), Biologic Products Database of the Spanish Society of Rheumatology ) in which was determined an association between infliximab therapy and the risk of developing active tuberculosis. To ensure the maintaining of the strict common physician practice (no prescription induction), and following the recommendations of the SER (Sociedad Española de Reumatología, Spanish Society of Rheumatology) consensus documents, it will be selected only those patients that were already in treatment with adalimumab (HUMIRA),(except patients involved in clinical studies with Adalimumab), and had shown good response, or those that fulfilled treatment indication in accordance with the SER recommendations and following the Summary of Products Characteristics of adalimumab (HUMIRA).

Detailed description: Main objective

* To evaluate safety and tolerability of adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions.

Secondary objectives

* To evaluate the effectiveness of the adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions in accordance with SER recommendations:
* To evaluate the life quality associated to the adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions.
* To describe the profile of patients who are in treatment with adalimumab (HUMIRA) biological therapy.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Patients who underwent adalimumab treatment at least for the previous 4 months before baseline visit, who have a good therapeutic response to treatment and have not been involved in previous clinical studies with Adalimumab or
* Patients who previously to the baseline visit, have been prescribe adalimumab complying treatment indication according to SER (Sociedad Española de Reumatología, Spanish Society of Rheumatology) recommendations:
* Patients who had provided informed consent.
* Patients who have been prescribed adalimumab according to the Summary of Product Characteristics

Exclusion Criteria:

* Patients in whom a continued 12- months follow up is not anticipated.
* The contraindications specified in the Summary of Products Characteristics
* Hypersensibility to some of the components of the medication to administer.
* Any pathology shown by the patient that, according to medical criterion, contraindicates the treatment indicated in the protocol according to the Summary of Products Characteristics of adalimumab (HUMIRA®).

Primary outcomes:
measure: Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment
timeFrame: Baseline, 1, 4, 6, and 12 months
Secondary outcomes:
measure: Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).
timeFrame: Baseline and 12 months
measure: Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).
timeFrame: Baseline and 12 months
measure: Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits.
timeFrame: Baseline, 1, 4, 6, and 12 months
measure: Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.
timeFrame: Baseline and 12 months
measure: Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.
timeFrame: Baseline and 12 Months
measure: Radiological Evaluation of Rheumatoid Arthritis (RA).
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: A Coruna
country: Spain
facility: Site Reference ID/Investigator# 29714
city: Algeciras
country: Spain
facility: Site Reference ID/Investigator# 29061
city: Almeria
country: Spain
facility: Site Reference ID/Investigator# 29710
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 29719
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 29054
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 29698
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 29063
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 29718
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 29720
city: Cadiz
country: Spain
facility: Site Reference ID/Investigator# 29706
city: Calella
country: Spain
facility: Site Reference ID/Investigator# 29052
city: Cartagena
country: Spain
facility: Site Reference ID/Investigator# 29065
city: Cordoba
country: Spain
facility: Site Reference ID/Investigator# 29713
city: El Palmar
country: Spain
facility: Site Reference ID/Investigator# 29703
city: Ferrol
country: Spain
facility: Site Reference ID/Investigator# 28607
city: Girona
country: Spain
facility: Site Reference ID/Investigator# 5338
city: Granada
country: Spain
facility: Site Reference ID/Investigator# 29701
city: Hospitalet de Llobregat
country: Spain
facility: Site Reference ID/Investigator# 29711
city: Huelva
country: Spain
facility: Site Reference ID/Investigator# 29705
city: Ibiza
country: Spain
facility: Site Reference ID/Investigator# 29050
city: Jaen
country: Spain
facility: Site Reference ID/Investigator# 29708
city: Jerez
country: Spain
facility: Site Reference ID/Investigator# 29709
city: Lugo
country: Spain
facility: Site Reference ID/Investigator# 29716
city: Malaga
country: Spain
facility: Site Reference ID/Investigator# 29700
city: Manacor
country: Spain
facility: Site Reference ID/Investigator# 29038
city: Mataro, Barcelona
country: Spain
facility: Site Reference ID/Investigator# 29712
city: Orense
country: Spain
facility: Site Reference ID/Investigator# 29051
city: Palma de Mallorca
country: Spain
facility: Site Reference ID/Investigator# 29699
city: Pamplona
country: Spain
facility: Site Reference ID/Investigator# 29717
city: Reus
country: Spain
facility: Site Reference ID/Investigator# 29704
city: Santiago de Compostela
country: Spain
facility: Site Reference ID/Investigator# 29715
city: Sevilla
country: Spain
facility: Site Reference ID/Investigator# 29068
city: Seville
country: Spain
facility: Site Reference ID/Investigator# 30823
city: Tarragona
country: Spain
facility: Site Reference ID/Investigator# 29064
city: Valls
country: Spain
facility: Site Reference ID/Investigator# 29058
city: Vic
country: Spain
facility: Site Reference ID/Investigator# 29055
city: Vigo/Pontevedra
country: Spain
facility: Site Reference ID/Investigator# 29702
city: Vigo
country: Spain
facility: Site Reference ID/Investigator# 29697
city: Vigo
country: Spain
facility: Site Reference ID/Investigator# 29059
city: Viladecans
country: Spain
facility: Site Reference ID/Investigator# 29053
Study officials:
affiliation: Abbott
name: Ana M Ruiz-Zorrilla, MD
role: STUDY_DIRECTOR
References: