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CompletedNCT01625650CERTAINUpdated Aug 22, 2018

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

An observational study in Rheumatoid Arthritis, sponsored by CorEvitas. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-22.

Sponsored by CorEvitas · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,795
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid Arthritis
  • Registry
  • RA
  • Biologic
  • Medications
  • Rheumatology
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 2,795 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

CorEvitas is the lead sponsor of 28 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Ppproximately 3,000 subjects from 100 sites will participate in this Sub-study and that approximately 30, and up to 200, subjects from this site will be enrolled.

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

Exclusion Criteria:

Disease other than RA that do not meet the inclusion criteria

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,795 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Rheumatology

    Patients who present at enrolling sites across the US are invited to enroll if eligible.

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Study locations

1 site
  • The Center For Rheumatoligy
    Albany, New York 12159, United States
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References and documents

Publications

  • Harrold LR, Bryson J, Lehman T, Zhuo J, Gao S, Han X, Schrader A, Rebello S, Pappas DA, Sommers T, Kremer JM. Association Between Baseline Anti-cyclic Citrullinated Peptide Antibodies and 6-Month Clinical Response Following Abatacept or TNF Inhibitor Treatment: A Real-World Analysis of Biologic-Experienced Patients with RA. Rheumatol Ther. 2021 Jun;8(2):937-953. doi: 10.1007/s40744-021-00310-2. Epub 2021 May 28. PubMed 34047953 ↗
  • Harrold LR, Litman HJ, Connolly SE, Alemao E, Kelly S, Rebello S, Hua W, Kremer JM. Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry. Rheumatol Ther. 2019 Jun;6(2):217-230. doi: 10.1007/s40744-019-0149-3. Epub 2019 Mar 13. PubMed 30868550 ↗
  • Pappas DA, John A, Curtis JR, Reed GW, Karki C, Magner R, Kremer JM, Shewade A, Greenberg JD. Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry. Rheumatol Ther. 2016 Jun;3(1):103-115. doi: 10.1007/s40744-016-0028-0. Epub 2016 Feb 8. PubMed 27747515 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01625650
Lead sponsor
CorEvitas
Collaborators
University of Alabama at Birmingham
Responsible party
Sponsor
First posted
Jun 21, 2012
Start date
Oct 2010
Primary completion
May 2015
Completion
May 2015
Last update
Aug 22, 2018

Study contacts

Dimitrios Pappas, MD, MPH
study chair · CORRONA INC.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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