N/A
Completed N=1,025
Observational Study to Explore the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)
Source: ClinicalTrials.gov NCT01383421 ↗Enrolled (actual)
1,025
Serious AEs
9.5%
Results posted
Jun 2017
Primary outcomePrimary: Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78 — 48.1; 37.8 percentage of participants — p=< 0.001
Summary
This study is a non-confirmatory post-marketing observational study to explore and describe the effectiveness of adalimumab on rheumatoid arthritis (RA) treatment course and participant satisfaction over time in context with utilization of a patient support program (PSP). The core elements of the PSP were call centers (in and outbound)/hotlines, nursing services, starter packs, provision of educational materials (print and digital) regarding RA and adalimumab, and injection guides. Other elements of the PSP, which varied between countries, included (but were not limited to) refill reminders, email contacts, support groups, and newsletters.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78 |
48.1; 37.8 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12 |
60.9; 50.0 | — |
| SECONDARY Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24 |
52.3; 46.4 | 0.058 |
| SECONDARY Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36 |
49.9; 43.0 | — |
| SECONDARY Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52 |
48.5; 39.2 | 0.003 sig |
| SECONDARY Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64 |
48.3; 37.3 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female aged at least 18 years that has been newly prescribed adalimumab therapy according to the local product label, with the first dose corresponding to the Enrollment/Baseline visit.
- Patient with a diagnosis of moderate to severe RA, who has had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs), and has a prescription of adalimumab according to the local regulations.
- Patients should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB (per local requirements and according to the local product label).
- Patients must be able and willing to provide written authorization to disclose and use personal health information (and informed consent where applicable) and comply with the requirements of this study protocol as well as agree to data being collected and provided to AbbVie.
Exclusion Criteria
- Patients should not be enrolled if they cannot be treated in accordance with the local adalimumab product label.
- Patients treated with > 1 prior biologic DMARD for RA. Any prior treatment with adalimumab is prohibited.
Data sourced from ClinicalTrials.gov (NCT01383421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.