Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: adalimumab (HUMIRA®) (Biological)
Phase: N/A
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Ana M Ruiz-Zorrilla, MD, Study Director, Affiliation: Abbott
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 ReumatologÃa, 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).
Clinical Details
Official title: Safety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study)
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: 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
Secondary outcome: 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).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). Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline. Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline. Radiological Evaluation of Rheumatoid Arthritis (RA).
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 ReumatologÃa,
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®).
Locations and Contacts
Site Reference ID/Investigator# 29714, A Coruna 15006, Spain
Site Reference ID/Investigator# 29061, Algeciras 11207, Spain
Site Reference ID/Investigator# 29710, Almeria 04009, Spain
Site Reference ID/Investigator# 29054, Barcelona 08025, Spain
Site Reference ID/Investigator# 29063, Barcelona 08035, Spain
Site Reference ID/Investigator# 29698, Barcelona 08025, Spain
Site Reference ID/Investigator# 29718, Barcelona 08035, Spain
Site Reference ID/Investigator# 29719, Barcelona 08003, Spain
Site Reference ID/Investigator# 29720, Barcelona 08036, Spain
Site Reference ID/Investigator# 29706, Cadiz 11009, Spain
Site Reference ID/Investigator# 29052, Calella 08370, Spain
Site Reference ID/Investigator# 29065, Cartagena 30203, Spain
Site Reference ID/Investigator# 29713, Cordoba 14004, Spain
Site Reference ID/Investigator# 29703, El Palmar 31120, Spain
Site Reference ID/Investigator# 28607, Ferrol 15405, Spain
Site Reference ID/Investigator# 5338, Girona 17002, Spain
Site Reference ID/Investigator# 29701, Granada 18014, Spain
Site Reference ID/Investigator# 29711, Hospitalet de Llobregat 08907, Spain
Site Reference ID/Investigator# 29705, Huelva 21080, Spain
Site Reference ID/Investigator# 29050, Ibiza 07800, Spain
Site Reference ID/Investigator# 29708, Jaen 23007, Spain
Site Reference ID/Investigator# 29709, Jerez 11407, Spain
Site Reference ID/Investigator# 29716, Lugo 27004, Spain
Site Reference ID/Investigator# 29700, Malaga 29009, Spain
Site Reference ID/Investigator# 29038, Manacor 07500, Spain
Site Reference ID/Investigator# 29712, Mataro, Barcelona 08304, Spain
Site Reference ID/Investigator# 29051, Orense 32005, Spain
Site Reference ID/Investigator# 29699, Palma de Mallorca 07014, Spain
Site Reference ID/Investigator# 29717, Pamplona 31000, Spain
Site Reference ID/Investigator# 29704, Reus 43201, Spain
Site Reference ID/Investigator# 29715, Santiago de Compostela 15706, Spain
Site Reference ID/Investigator# 29068, Sevilla 41013, Spain
Site Reference ID/Investigator# 30823, Seville 41009, Spain
Site Reference ID/Investigator# 29064, Tarragona 43003, Spain
Site Reference ID/Investigator# 29058, Valls 43800, Spain
Site Reference ID/Investigator# 29055, Vic 08500, Spain
Site Reference ID/Investigator# 29702, Vigo/Pontevedra 36200, Spain
Site Reference ID/Investigator# 29059, Vigo 36211, Spain
Site Reference ID/Investigator# 29697, Vigo 36204, Spain
Site Reference ID/Investigator# 29053, Viladecans 08840, Spain
Additional Information
Starting date: May 2006
Last updated: October 26, 2011
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