Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Anti-TNF, Adalimumab, Infliximab, Etanercept
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Abbott
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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: 1. ≥3 tender joints and ≥3 swollen joints, or 2. DAS 28 score \>3.1 * Patients who are discontinuing treatment with either infliximab or etanercept due to: 1. Lack of efficacy, or 2. Incomplete response. * 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: * Patients who have active infections. * Patients with latent TB. For this protocol, evidence of latent TB infection is defined as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement. Any suggested data on the clinical history or chest x-ray. * Patients participating into another study or clinical trial * Any condition that according to the criteria of the participating physician represents an obstacle for study conduct and/or represents a potential unacceptable risk for patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DAS28 (Disease Activity Score in 28 Joints) | Baseline and Weeks 8,16 and 24 | 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. |
| Tender Joint Count and Swollen Joint Count | Baseline and Weeks 8,16 and 24 | 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. |
| Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) | Baseline and Weeks 8,16 and 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Compliance and Clinical Tolerability With Adalimumab | Baseline to Week 24 | 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. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Non Responders to Other Anti-TNF |
|---|---|
| Age Continuous | 48.34 years STANDARD_DEVIATION 11.56 |
| Region of Enrollment Mexico | 82 participants |
| Sex/Gender, Customized Female | 66 participants |
| Sex/Gender, Customized Gender not reported | 3 participants |
| Sex/Gender, Customized Male | 13 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 82 |
| serious Total, serious adverse events | 1 / 82 |
Outcome results
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.
Time frame: Baseline and Weeks 8,16 and 24
Population: Analysis conducted in participants with results at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non Responders to Other Anti-TNF | DAS28 (Disease Activity Score in 28 Joints) | DAS 28 at Baseline (n=82) | 6.04 units on a scale | Standard Deviation 1.17 |
| Non Responders to Other Anti-TNF | DAS28 (Disease Activity Score in 28 Joints) | DAS 28 at Week 8 (n=80) | 4.63 units on a scale | Standard Deviation 1.77 |
| Non Responders to Other Anti-TNF | DAS28 (Disease Activity Score in 28 Joints) | DAS 28 at Week 16 (n=79) | 4.05 units on a scale | Standard Deviation 1.74 |
| Non Responders to Other Anti-TNF | DAS28 (Disease Activity Score in 28 Joints) | DAS 28 at Week 24 (n=71) | 3.68 units on a scale | Standard Deviation 1.47 |
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.
Time frame: Baseline and Weeks 8,16 and 24
Population: Analysis conducted in participants with results at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non Responders to Other Anti-TNF | Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) | VAS at Baseline (n=82) | 62.88 Units on a scale | Standard Deviation 22.31 |
| Non Responders to Other Anti-TNF | Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) | >Week 8 (n=80) | 39.69 Units on a scale | Standard Deviation 25.4 |
| Non Responders to Other Anti-TNF | Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) | >Week 16 (n=80) | 32.35 Units on a scale | Standard Deviation 26.02 |
| Non Responders to Other Anti-TNF | Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm) | >Week 24 (n=71) | 28.70 Units on a scale | Standard Deviation 23.32 |
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.
Time frame: Baseline and Weeks 8,16 and 24
Population: Analysis conducted in participants with results at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non Responders to Other Anti-TNF | Tender Joint Count and Swollen Joint Count | Tender joints at Baseline (n=82) | 13.05 Joints | Standard Deviation 7.29 |
| Non Responders to Other Anti-TNF | Tender Joint Count and Swollen Joint Count | > Week 8 (n=80) | 7.16 Joints | Standard Deviation 6.37 |
| Non Responders to Other Anti-TNF | Tender Joint Count and Swollen Joint Count | >Week 16 (n=80) | 5.44 Joints | Standard Deviation 5.76 |
| Non Responders to Other Anti-TNF | Tender Joint Count and Swollen Joint Count | >Week 24 (n=71) | 4.23 Joints | Standard Deviation 5.32 |
| Non Responders to Other Anti-TNF | Tender Joint Count and Swollen Joint Count | Swollen joints at Baseline (n=82) | 9.56 Joints | Standard Deviation 5.97 |
| Non Responders to Other Anti-TNF | Tender Joint Count and Swollen Joint Count | >Week 8 (n=80) | 4.48 Joints | Standard Deviation 4.68 |
| Non Responders to Other Anti-TNF | Tender Joint Count and Swollen Joint Count | >Week 16 (n=80) | 3.15 Joints | Standard Deviation 4.67 |
| Non Responders to Other Anti-TNF | Tender Joint Count and Swollen Joint Count | >Week 24 (n=71) | 2.52 Joints | Standard Deviation 4.1 |
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.
Time frame: Baseline to Week 24
Population: Analysis population included all participants enrolled in the study who took at least one dose of adalimumab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non Responders to Other Anti-TNF | Evaluate the Compliance and Clinical Tolerability With Adalimumab | Reported 1 missed dose at Week 8 | 1 Participants |
| Non Responders to Other Anti-TNF | Evaluate the Compliance and Clinical Tolerability With Adalimumab | Reported 2 missed doses at Week 8 | 3 Participants |
| Non Responders to Other Anti-TNF | Evaluate the Compliance and Clinical Tolerability With Adalimumab | Reported 2 missed doses at Week 16 | 1 Participants |
| Non Responders to Other Anti-TNF | Evaluate the Compliance and Clinical Tolerability With Adalimumab | Reported 3 missed doses at Week 16 | 1 Participants |
| Non Responders to Other Anti-TNF | Evaluate the Compliance and Clinical Tolerability With Adalimumab | Experienced a non-serious adverse event | 6 Participants |
| Non Responders to Other Anti-TNF | Evaluate the Compliance and Clinical Tolerability With Adalimumab | Experienced a serious adverse event | 1 Participants |