Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis (DALI)

Safety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study)

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).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: 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.

• Study Type: Observational
• Enrollment (Actual): 705

Contacts and Locations

Study Locations

• Spain
  • A Coruna, Spain, 15006
    • Site Reference ID/Investigator# 29714
  • Algeciras, Spain, 11207
    • Site Reference ID/Investigator# 29061
  • Almeria, Spain, 04009
    • Site Reference ID/Investigator# 29710
  • Barcelona, Spain, 08003
    • Site Reference ID/Investigator# 29719
  • Barcelona, Spain, 08025
    • Site Reference ID/Investigator# 29054
  • Barcelona, Spain, 08025
    • Site Reference ID/Investigator# 29698
  • Barcelona, Spain, 08035
    • Site Reference ID/Investigator# 29063
  • Barcelona, Spain, 08035
    • Site Reference ID/Investigator# 29718
  • Barcelona, Spain, 08036
    • Site Reference ID/Investigator# 29720
  • Cadiz, Spain, 11009
    • Site Reference ID/Investigator# 29706
  • Calella, Spain, 08370
    • Site Reference ID/Investigator# 29052
  • Cartagena, Spain, 30203
    • Site Reference ID/Investigator# 29065
  • Cordoba, Spain, 14004
    • Site Reference ID/Investigator# 29713
  • El Palmar, Spain, 31120
    • Site Reference ID/Investigator# 29703
  • Ferrol, Spain, 15405
    • Site Reference ID/Investigator# 28607
  • Girona, Spain, 17002
    • Site Reference ID/Investigator# 5338
  • Granada, Spain, 18014
    • Site Reference ID/Investigator# 29701
  • Hospitalet de Llobregat, Spain, 08907
    • Site Reference ID/Investigator# 29711
  • Huelva, Spain, 21080
    • Site Reference ID/Investigator# 29705
  • Ibiza, Spain, 07800
    • Site Reference ID/Investigator# 29050
  • Jaen, Spain, 23007
    • Site Reference ID/Investigator# 29708
  • Jerez, Spain, 11407
    • Site Reference ID/Investigator# 29709
  • Lugo, Spain, 27004
    • Site Reference ID/Investigator# 29716
  • Malaga, Spain, 29009
    • Site Reference ID/Investigator# 29700
  • Manacor, Spain, 07500
    • Site Reference ID/Investigator# 29038
  • Mataro, Barcelona, Spain, 08304
    • Site Reference ID/Investigator# 29712
  • Orense, Spain, 32005
    • Site Reference ID/Investigator# 29051
  • Palma de Mallorca, Spain, 07014
    • Site Reference ID/Investigator# 29699
  • Pamplona, Spain, 31000
    • Site Reference ID/Investigator# 29717
  • Reus, Spain, 43201
    • Site Reference ID/Investigator# 29704
  • Santiago de Compostela, Spain, 15706
    • Site Reference ID/Investigator# 29715
  • Sevilla, Spain, 41013
    • Site Reference ID/Investigator# 29068
  • Seville, Spain, 41009
    • Site Reference ID/Investigator# 30823
  • Tarragona, Spain, 43003
    • Site Reference ID/Investigator# 29064
  • Valls, Spain, 43800
    • Site Reference ID/Investigator# 29058
  • Vic, Spain, 08500
    • Site Reference ID/Investigator# 29055
  • Vigo, Spain, 36204
    • Site Reference ID/Investigator# 29697
  • Vigo, Spain, 36211
    • Site Reference ID/Investigator# 29059
  • Vigo/Pontevedra, Spain, 36200
    • Site Reference ID/Investigator# 29702
  • Viladecans, Spain, 08840
    • Site Reference ID/Investigator# 29053

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Rheumatologist consultant

Description

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®).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RA patients in treatment with adalimumab (Humira); RA patients in treatment with adalimumab (Humira) at 40mg alternate weeks	Biological: adalimumab (HUMIRA®); The primary objective of the study is to evaluate the safety and tolerability of adalimumab (HUMIRA®) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis (RA) patients under usual practice conditions.; Other Names: HUMIRA®; adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events.	Baseline, 1, 4, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to final is presented.	Baseline and 12 months
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).	The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from "very good" to "very bad"). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The percentage reduction of baseline values is presented.	Baseline and 12 months
Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits.	The treating physician was to clinically assess each participant at each study visit and report the number of painful and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented by subgroup. The number of participants evaluated in each subgroup at each time point are also reported.	Baseline, 1, 4, 6, and 12 months
Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.	Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The mean change in global HAQ score from baseline to 12 months is reported (baseline value - final value).	Baseline and 12 months
Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.	Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The percentage change from baseline to 12 months (12-month score minus baseline score divided by baseline score) is presented.	Baseline and 12 Months
Radiological Evaluation of Rheumatoid Arthritis (RA).	Treating physicians were asked to obtain a structural damage assessment by performing x-rays of the hands and feet approximately 1 year after the previous structural damage assessment that was done prior to the participant entering the study. The number of participants with radiological erosions evaluated at baseline and the 12-month visit are summarized by subgroup.	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Ana M Ruiz-Zorrilla, MD, Abbott

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: March 1, 2010
• First Submitted That Met QC Criteria: March 1, 2010
• First Posted (Estimate): March 2, 2010

Study Record Updates

• Last Update Posted (Estimate): October 28, 2011
• Last Update Submitted That Met QC Criteria: October 26, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Biologic; Tumor Necrosis Factors blockers agents Monoclonal antibody
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: P10-077

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No