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The study was terminated due to low enrollment because inclusion criteria are obsolete.
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This is a prospective, single-arm, post marketing observational study in adult patients with active rheumatoid arthritis (RA) who are discontinuing treatment due to lack of efficacy, intolerance or to an incomplete response with either infliximab or etanercept.
The aim of this post-marketing observational study is to obtain data on clinical outcomes, compliance and tolerability to determine the effectiveness of switching from infliximab or etanercept to adalimumab. In this cohort, the different treatment strategies are to be studied in the context of the routine clinical practice in the different participating places.
This is a prospective, single-arm, post marketing observational study in adult patients with active RA who are discontinuing treatment due to lack of efficacy, intolerance or to an incomplete response with either infliximab or etanercept.
The aim of this post-marketing observational study is to obtain data on clinical outcomes, compliance and tolerability to determine the effectiveness of switching from infliximab or etanercept to Adalimumab. In this cohort, the different treatment strategies are to be studied in the context of the routine clinical practice in the different participating places.
Study Objectives:
Primary objective:
To assess the effectiveness of the treatment with adalimumab in patients with rheumatoid arthritis (RA) that have failed or presented an incomplete response to current treatment with either infliximab or etanercept.
Secondary objective:
To evaluate the compliance and clinical tolerability with adalimumab
Investigational Plan and Selection of Study Population:
All patients belonging to any of the centres participating in the study that meet all the inclusion criteria and none of the exclusion criteria will be considered eligible.
Patients considered eligible for the study will have to give their consent for the use and/or disclose of the patient's personal and/or health data. Patient's consent will be obtained before his/her participation in the study and will be documented in an Informed Consent Form approved by an Ethics Committee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non responders to other anti-TNF | Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| DAS28 (Disease Activity Score in 28 Joints) | 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 each visit is presented. | Baseline and Weeks 8,16 and 24 |
| Tender Joint Count and Swollen Joint Count | The treating physician was to clinically assess each participant at each study visit and report the number of tender and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented. | Baseline and Weeks 8,16 and 24 |
| Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) | Participants assessed the severity of their pain using a 0 to 100 mm horizontal visual analogue scale (VAS). The far left end indicated no pain (0 mm) and the far right meant the worst possible pain (100 mm). Participants drew a vertical line on the horizontal scale to indicate their current level of pain at each visit. | Baseline and Weeks 8,16 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Compliance and Clinical Tolerability With Adalimumab | To assess compliance, participants were asked at the Week 8 and Week 16 visits how many doses they had missed since their previous visit. Adverse events were collected throughout the study, from the time the participant signed the informed consent form until 30 days or 5 half-lives after the last dose of study drug. For additional information see the Reported Adverse Event section. |
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Inclusion Criteria:
Patients ≥18 and <75 years of age that meet the American College of Rheumatology (ACR) criteria for RA.
Patients with active RA defined as:
Patients who are discontinuing treatment with either infliximab or etanercept due to:
Patients that, in the opinion of the physician could result beneficiated with the locally approved treatment scheme of adalimumab
Those patients who switch from infliximab or etanercept to adalimumab has been done in the last 60 days could be included in the study.
Exclusion Criteria:
The following patients will not be included in the study:
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Community sample
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| Name | Affiliation | Role |
|---|---|---|
| Juan Pozos, MD | Abbott | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 27882 | Chihuahua City | 31000 | Mexico | |||
| Site Reference ID/Investigator# 27883 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non Responders to Other Anti-TNF | Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to Week 24 |
| Chihuahua City |
| 31200 |
| Mexico |
| Site Reference ID/Investigator# 27884 | Culiacán Sin. | 80000 | Mexico |
| Site Reference ID/Investigator# 27888 | Guadalajara, Jal. | 44320 | Mexico |
| Site Reference ID/Investigator# 27886 | Guadalajara, Jal. | 44650 | Mexico |
| Site Reference ID/Investigator# 27887 | Guadalajara, Jal. | 44670 | Mexico |
| Site Reference ID/Investigator# 25943 | Leon, Gto. | 37000 | Mexico |
| Site Reference ID/Investigator# 28059 | Mexico City | 03100 | Mexico |
| Site Reference ID/Investigator# 27885 | Mexico City | 06700 | Mexico |
| Site Reference ID/Investigator# 27890 | Puebla, Pue. | 72000 | Mexico |
| Site Reference ID/Investigator# 27889 | Puebla, Pue. | 72570 | Mexico |
| Site Reference ID/Investigator# 28057 | Tuxtla Gutiérrez | 29000 | Mexico |
| Evaluable Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non Responders to Other Anti-TNF | Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | DAS28 (Disease Activity Score in 28 Joints) | 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 each visit is presented. | Analysis conducted in participants with results at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 8,16 and 24 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Tender Joint Count and Swollen Joint Count | The treating physician was to clinically assess each participant at each study visit and report the number of tender and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented. | Analysis conducted in participants with results at each time point. | Posted | Mean | Standard Deviation | Joints | Baseline and Weeks 8,16 and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) | Participants assessed the severity of their pain using a 0 to 100 mm horizontal visual analogue scale (VAS). The far left end indicated no pain (0 mm) and the far right meant the worst possible pain (100 mm). Participants drew a vertical line on the horizontal scale to indicate their current level of pain at each visit. | Analysis conducted in participants with results at each time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Weeks 8,16 and 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Evaluate the Compliance and Clinical Tolerability With Adalimumab | To assess compliance, participants were asked at the Week 8 and Week 16 visits how many doses they had missed since their previous visit. Adverse events were collected throughout the study, from the time the participant signed the informed consent form until 30 days or 5 half-lives after the last dose of study drug. For additional information see the Reported Adverse Event section. | Analysis population included all participants enrolled in the study who took at least one dose of adalimumab. | Posted | Number | Participants | Baseline to Week 24 |
|
|
Duration of study participation was 24 weeks. Adverse events were collected from the time the participant signed the informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non Responders to Other Anti-TNF | Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks. | 1 | 82 | 6 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rectal bleeding | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Phosphenes | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Swelling in administration site | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rhinorrea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Gender not reported |
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| Title | Measurements |
|---|---|
|
| DAS 28 at Week 24 (n=71) |
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