Rheumatoid ArthritisDALINCT01078571
Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Abbott at 40 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- adalimumab (HUMIRA®)
- How many people
- 705 participants
- Where
- 40 sitesSpain
- Study dates
- May 2006to May 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatologist consultant
Who may be able to join
- 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
Who cannot join
- 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®).
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Spain40 sites
Site Reference ID/Investigator# 29714
A Coruña, 15006
Site Reference ID/Investigator# 29061
Algeciras, 11207
Site Reference ID/Investigator# 29710
Almería, 04009
Site Reference ID/Investigator# 29719
Barcelona, 08003
Site Reference ID/Investigator# 29054
Barcelona, 08025
Site Reference ID/Investigator# 29698
Barcelona, 08025
Site Reference ID/Investigator# 29063
Barcelona, 08035
Site Reference ID/Investigator# 29718
Barcelona, 08035
Site Reference ID/Investigator# 29720
Barcelona, 08036
Site Reference ID/Investigator# 29706
Cadiz, 11009
Site Reference ID/Investigator# 29052
Calella, 08370
Site Reference ID/Investigator# 29065
Cartagena, 30203
Site Reference ID/Investigator# 29713
Córdoba, 14004
Site Reference ID/Investigator# 29703
El Palmar, 31120
Site Reference ID/Investigator# 28607
Ferrol, 15405
Site Reference ID/Investigator# 5338
Girona, 17002
Site Reference ID/Investigator# 29701
Granada, 18014
Site Reference ID/Investigator# 29705
Huelva, 21080
Site Reference ID/Investigator# 29050
Ibiza Town, 07800
Site Reference ID/Investigator# 29708
Jaén, 23007
Site Reference ID/Investigator# 29709
Jerez de la Frontera, 11407
Site Reference ID/Investigator# 29711
L'Hospitalet de Llobregat, 08907
Site Reference ID/Investigator# 29716
Lugo, 27004
Site Reference ID/Investigator# 29700
Málaga, 29009
Site Reference ID/Investigator# 29038
Manacor, 07500
Site Reference ID/Investigator# 29712
Mataro, Barcelona, 08304
Site Reference ID/Investigator# 29051
Ourense, 32005
Site Reference ID/Investigator# 29699
Palma de Mallorca, 07014
Site Reference ID/Investigator# 29717
Pamplona, 31000
Site Reference ID/Investigator# 29704
Reus, 43201
Site Reference ID/Investigator# 29715
Santiago de Compostela, 15706
Site Reference ID/Investigator# 30823
Seville, 41009
Site Reference ID/Investigator# 29068
Seville, 41013
Site Reference ID/Investigator# 29064
Tarragona, 43003
Site Reference ID/Investigator# 29058
Valls, 43800
Site Reference ID/Investigator# 29055
Vic, 08500
Site Reference ID/Investigator# 29697
Vigo, 36204
Site Reference ID/Investigator# 29059
Vigo, 36211
Site Reference ID/Investigator# 29702
Vigo/Pontevedra, 36200
Site Reference ID/Investigator# 29053
Viladecans, 08840
About this study
Official title: 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).
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- adalimumab (HUMIRA®)
- Keywords
- Rheumatoid Arthritis, Biologic, Tumor Necrosis Factors blockers agents Monoclonal antibody
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumab (HUMIRA®)Biological
Also called HUMIRA®, adalimumab
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.
| Study group | Role | What they receive |
|---|---|---|
| RA patients in treatment with adalimumab (Humira) | RA patients in treatment with adalimumab (Humira) at 40mg alternate weeks Receives: Biological: adalimumab (HUMIRA®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1, 4, 6, and 12 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startMay 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana M Ruiz-Zorrilla, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078571
- Sponsor's protocol ID
- P10-077
- Acronym
- DALI
- Status last verified
- Oct 2011
- First submitted
- 1 Mar 2010
- Last updated
- 28 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study)
- ClinicalTrials.gov ID
- NCT01078571
- Acronym / sponsor ID
- DALI / P10-077
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Biologic, Tumor Necrosis Factors blockers agents Monoclonal antibody
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Posted 25 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA patients in treatment with adalimumab (Humira) | – | Biological: adalimumab (HUMIRA®)RA patients in treatment with adalimumab (Humira) at 40mg alternate weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatologist consultant
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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®).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumab (HUMIRA®)Also: HUMIRA®, adalimumabThe 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. | Biological | RA patients in treatment with adalimumab (Humira) |
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
Time frame: Baseline, 1, 4, 6, and 12 months
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.
6 secondary outcomes
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
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
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
Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.
Time frame: Baseline and 12 months
Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.
Time frame: Baseline and 12 Months
Radiological Evaluation of Rheumatoid Arthritis (RA).
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana M Ruiz-Zorrilla, MD study director
Abbott
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Abbott at 40 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline, 1, 4, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2011.