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Effectiveness Registry to Study Therapies for Arthritis and Inflammatory Conditions: The Corrona CERTAIN Sub-study

The Corrona Effectiveness Registry to Study Therapies for Arthritis and Inflammatory Conditions Sub-study: The Corrona CERTAIN Sub-study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01625650
Acronym
CERTAIN
Enrollment
2795
Registered
2012-06-21
Start date
2010-10-31
Completion date
2015-05-31
Last updated
2018-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Registry, RA, Biologic, Medications, Rheumatology

Brief summary

The CORRONA CERTAIN Sub-study of the Consortium of Rheumatology Researchers of North America, Inc. is a Sub-study of the CORRONA Data Collection Program. The CERTAIN Sub-study is designed to systematically collect and document use patterns, effectiveness, comparative effectiveness and safety of biologic agents used in the management of Rheumatoid Arthritis (RA).

Detailed description

Biologic therapies (including biologic medications like Enbrel, Humira, Remicade, Cimzia, Simponi, Actemra, Rituxan and Orencia) have changed the treatment of RA, but the differences in safety and/or effectiveness of each biologic therapy are not all known. We are doing this study in order to try to see if one or more of these treatments are better than the others. The use of databases like the CORRONA Organization database gives us information that helps us to understand why such drugs are used, reasons for starting or stopping drugs, for whom they are prescribed, and to monitor changes in patients' abilities to perform daily activities and gather information on family or social history.

Interventions

None listed

Sponsors

University of Alabama at Birmingham
CollaboratorOTHER
CorEvitas
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* The CORRONA CERTAIN Sub-study is particularly focused on understanding the effectiveness and safety of biologic medications. Male and female patients, who 1. are at least 18 years of age; 2. have a documented diagnosis of RA by their treating rheumatologist; 3. have at least moderate disease activity; and 4. are initiating a biologic agent that has not be used for their treatment in the past are eligible to participate. Moderate disease activity is defined by a CDAI score greater than 10.

Exclusion criteria

Disease other than RA that do not meet the inclusion criteria

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026