Comparing the Effectiveness of a Treat-to-target (T2T) Disease Management Strategy vs. Routine Care (RC) in Adult Patients With Moderate to Severe Rheumatoid Arthritis (RA) Treated With Subcutaneous Abatacept (Orencia - SC)

NCT03274141 | Completed

• 1 other identifier: IM101-331
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 12 month prospective, multicenter, post-marketing, observational study to compare the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with subcutaneous abatacept (Orencia - SC). Patients completing the study will be offered to participate in a 12-month extension of their follow-up provided that this is in agreement with the judgment of the treating physician.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Number of T2T patients achieving sustained CDAI LDA

  Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.

  Approximately 1 year

• Number of RC patients achieving sustained CDAI LDA

  Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.

  Approximately 1 year

Secondary Outcomes (35)

• Number of patients achieving SDAI remission

  Up to 24 months

• Mean time for patients to achieve SDAI remission

  Up to 24 months

• Number of patients achieving CDAI remission

  Up to 24 months

• Mean time for patients to achieve CDAI remission

  Up to 24 months

• Number of patients achieving DAS28-CRP LDA

  Up to 24 months

Study Arms (2)

T2T Patients

RA patients managed with a treat-to-target (T2T) strategy

Other: Non-Interventional

RC Patients

RA patients managed with routine care(RC)

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Interventional

RC Patients; T2T Patients

Eligibility Criteria

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

Study Population

Adult patients with active RA defined as a CDAI \> 10 for whom the treating physician has made the decision to initiate treatment with SC abatacept according to the approved Canadian product monograph and regional reimbursement criteria will be potentially eligible for inclusion in the study. The decision to treat the patient with SC abatacept must have been reached prior to and independently of considering the patient for study enrollment.

You may qualify if:

• years of age or older.
• Active moderate to severe RA, defined as CDAI \> 10.
• The treating physician has made the decision to initiate treatment with SC abatacept in accordance with the Canadian product monograph.
• Patient has provided a written informed consent and is able to complete the survey requirements.
• Patient fulfills the reimbursement criteria for treatment with SC abatacept under provincial or private health insurance reimbursement coverage.

You may not qualify if:

• Has received abatacept (SC or IV) prior to the enrolment visit.
• Has failed more than one prior biologic DMARD therapy
• Has a history of autoimmune disease or of any joint inflammatory disease other than RA with the exception of concomitant secondary Sjogren's syndrome.
• Is participating in an ongoing clinical trial and/or has received treatment with an investigational agent within 4 weeks before starting treatment with SC abatacept.
• Is participating in another industry-sponsored observational study.
• Patients participating to non-industry related registries or other data collection studies can be included
• Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of RA treatment.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Westmount, Quebec, H3Z 1R7, Canada

Location

Related Publications (1)

• Bessette L, Haraoui B, Rampakakis E, Dembowy J, Trepanier MO, Pope J. Effectiveness of a treat-to-target strategy in patients with moderate to severely active rheumatoid arthritis treated with abatacept. Arthritis Res Ther. 2023 Sep 28;25(1):183. doi: 10.1186/s13075-023-03151-2.

  PMID: 37759330 DERIVED

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 6, 2017
• Study Start: October 31, 2011
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

CA (1)