Observational Study to Explore the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)

NCT01383421 | Completed Results

• 1 other identifier: P12-072
• Study Type: observational
• Target: 1,036
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Patient Support Program; adalimumab

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78

  The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.

  Baseline, Week 78

Secondary Outcomes (5)

• Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12

  Baseline, Week 12

• Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24

  Baseline, Week 24

• Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36

  Baseline, Week 36

• Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52

  Baseline, Week 52

• Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64

  Baseline, Week 64

Other Outcomes (21)

• Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78

  Baseline and Weeks 24, 52, 78

• Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78

  Baseline, Weeks 24, 52, and 78

• Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78

  Baseline, Weeks 24, 52, and 78

Study Arms (1)

Participants With RA Receiving Adalimumab

Participants with RA who were prescribed adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit. All participants were offered to participate in the PSP while treated with ADA for their RA.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Representative disease population selected from rheumatology clinics in the countries selected.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Publications (1)

• Van den Bosch F, Ostor AJK, Wassenberg S, Chen N, Wang C, Garg V, Kalabic J. Impact of Participation in the Adalimumab (Humira) Patient Support Program on Rheumatoid Arthritis Treatment Course: Results from the PASSION Study. Rheumatol Ther. 2017 Jun;4(1):85-96. doi: 10.1007/s40744-017-0061-7. Epub 2017 Mar 30.

  PMID: 28361468 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor Abbott)

800-633-9110

Study Officials

• Jasmina Kalabic, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2011
• First Posted: June 28, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 26, 2017
• Results First Posted: June 26, 2017

Record last verified: 2017-04