NCT03457792

Brief Summary

This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 17, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

4 years

First QC Date

February 13, 2018

Last Update Submit

June 10, 2022

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Number of patients continuing with abatacept treatment

    Up to 12 months

Secondary Outcomes (25)

  • Anti-citrullinated protein antibody (ACPA) titer

    At baseline

  • Concomitant treatment given with abatacept as determined by the investigator

    Up to 12 months

  • Dosage of abatacept as determined by the investigator

    Up to 12 months

  • Frequency of administration of abatacept

    Up to 12 months

  • Reason for abatacept treatment initiation as determined by the investigator

    At baseline

  • +20 more secondary outcomes

Study Arms (1)

Abatacept for Rheumatoid Arthritis (RA)

Participants diagnosed with moderate to severe active RA within the last 24 months and initiated treatment with Abatacept

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participant population targeted in this study consists of participants with early-stage RA (i.e. diagnosis of RA not longer than 24 months) that initiate treatment with Abatacept.

You may qualify if:

  • Participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active RA
  • Participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the German label/SmPC (Summary of product characteristics)

You may not qualify if:

  • Participants who are currently included in any interventional clinical trial in RA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Freiburg im Breisgau, 79095, Germany

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune 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

February 13, 2018

First Posted

March 8, 2018

Study Start

April 17, 2018

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

June 14, 2022

Record last verified: 2022-06

Locations

DE(1)