An observational study in Rheumatoid Arthritis, sponsored by Abbott. Terminated at 12 sites in Mexico. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-01-19.
Sponsored by Abbott · Observational
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 82 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Community sample
Patients with active RA defined as:
Patients who are discontinuing treatment with either infliximab or etanercept due to:
Exclusion Criteria:
The following patients will not be included in the study:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Weeks 8,16 and 24
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.
Time frame: Baseline to Week 24
| Milestone | Non Responders to Other Anti-TNF |
|---|---|
| Started | 82 |
| Evaluable population | 71 |
| Completed | 81 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
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.
| units on a scale | Non Responders to Other Anti-TNF |
|---|---|
| DAS 28 at Baseline (n=82) | 6.04 ± 1.17 |
| DAS 28 at Week 8 (n=80) | 4.63 ± 1.77 |
| DAS 28 at Week 16 (n=79) | 4.05 ± 1.74 |
| DAS 28 at Week 24 (n=71) | 3.68 ± 1.47 |
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.
| Joints | Non Responders to Other Anti-TNF |
|---|---|
| Tender joints at Baseline (n=82) | 13.05 ± 7.29 |
| > Week 8 (n=80) | 7.16 ± 6.37 |
| >Week 16 (n=80) | 5.44 ± 5.76 |
| >Week 24 (n=71) | 4.23 ± 5.32 |
| Swollen joints at Baseline (n=82) | 9.56 ± 5.97 |
| >Week 8 (n=80) | 4.48 ± 4.68 |
| >Week 16 (n=80) | 3.15 ± 4.67 |
| >Week 24 (n=71) | 2.52 ± 4.10 |
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.
| Units on a scale | Non Responders to Other Anti-TNF |
|---|---|
| VAS at Baseline (n=82) | 62.88 ± 22.31 |
| >Week 8 (n=80) | 39.69 ± 25.40 |
| >Week 16 (n=80) | 32.35 ± 26.02 |
| >Week 24 (n=71) | 28.70 ± 23.32 |
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.
| Participants | Non Responders to Other Anti-TNF |
|---|---|
| Reported 1 missed dose at Week 8 | 1 |
| Reported 2 missed doses at Week 8 | 3 |
| Reported 2 missed doses at Week 16 | 1 |
| Reported 3 missed doses at Week 16 | 1 |
| Experienced a non-serious adverse event | 6 |
| Experienced a serious adverse event | 1 |
Collected over 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.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non Responders to Other Anti-TNF | — | 1/82 (1.2%) | 6/82 (7.3%) |
| Event | Non Responders to Other Anti-TNF |
|---|---|
| rectal bleedingGastrointestinal disorders | 1/82 |
| Event | Non Responders to Other Anti-TNF |
|---|---|
| Upper respiratory tract infectionInfections and infestations | 2/82 |
| ConstipationGastrointestinal disorders | 1/82 |
| VomitingGastrointestinal disorders | 1/82 |
| AstheniaGeneral disorders | 1/82 |
| ChillsGeneral disorders | 1/82 |
| PhosphenesGeneral disorders | 1/82 |
| PainGeneral disorders | 1/82 |
| Swelling in administration siteInjury, poisoning and procedural complications | 1/82 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/82 |
| RhinorreaRespiratory, thoracic and mediastinal disorders | 1/82 |
| Age Continuous(years) | Non Responders to Other Anti-TNF |
|---|---|
| Mean | 48.34 ± 11.56 |
| Sex/Gender, Customized(participants) | Non Responders to Other Anti-TNF |
|---|---|
| Female | 66 |
| Male | 13 |
| Gender not reported | 3 |
| Region of Enrollment(participants) | Non Responders to Other Anti-TNF |
|---|---|
| Mexico | 82 |
This study is terminated, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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