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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01078571
First received: March 1, 2010
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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).


Condition Intervention
Rheumatoid Arthritis
Biological: adalimumab (HUMIRA®)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline, 1, 4, 6, and 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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). [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
    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.

  • 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). [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. [ Time Frame: Baseline, 1, 4, 6, and 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline. [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
    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).

  • Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline. [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: Yes ]
    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.

  • Radiological Evaluation of Rheumatoid Arthritis (RA). [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 705
Study Start Date: May 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Rheumatologist consultant

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®).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078571

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01078571     History of Changes
Other Study ID Numbers: P10-077
Study First Received: March 1, 2010
Results First Received: May 27, 2011
Last Updated: October 26, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Abbott:
Rheumatoid Arthritis
Biologic
Tumor Necrosis Factors blockers agents Monoclonal antibody

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 20, 2014