NCT01625650

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,795

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

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

Study Start

First participant enrolled

October 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 22, 2018

Status Verified

February 1, 2016

Enrollment Period

4.6 years

First QC Date

June 19, 2012

Last Update Submit

August 20, 2018

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisRegistryRABiologicMedicationsRheumatology

Study Arms (1)

Rheumatology

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • The CORRONA CERTAIN Sub-study is particularly focused on understanding the effectiveness and safety of biologic medications. Male and female patients, who
  • are at least 18 years of age;
  • have a documented diagnosis of RA by their treating rheumatologist;
  • have at least moderate disease activity; and
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center For Rheumatoligy

Albany, New York, 12159, United States

Location

Related Publications (3)

  • 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.

    PMID: 34047953DERIVED

  • 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.

    PMID: 30868550DERIVED

  • 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.

    PMID: 27747515DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood tests: at each study blood is obtained to examine, lipid levels with direct ( non fasting) LDL, a high sensitivity CRP as well as toxicity monitoring labs including a complete blood count and a comprehensive panel. During the baseline visit DNA is collected upon consent - to allow future genetic and pharmacogenetic studies- and also serology markers and immunoglobulin levels. During the first three visits RNA serum and plasma for storage and future experiments are collected.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Dimitrios Pappas, MD, MPH

    CORRONA INC.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 21, 2012

Study Start

October 1, 2010

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 22, 2018

Record last verified: 2016-02

Locations

US(1)