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Rheumatoid ArthritisNCT01402661

CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry

An observational study of Rheumatoid Arthritis, run by CorEvitas at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for RA in a cohort of patients cared for by rheumatologists across North America. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
How many people
91,758 participants
Where
1 siteUnited States
Study dates
Feb 2002to Dec 2100
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients are enrolled in the CorEvitas Data Collection Program during regularly-scheduled office visits. Selected rheumatologists are invited to participate as investigators in the CorEvitas Data Collection Program. Physicians are selected carefully in an effort to ensure enrollment of subjects that represent a reasonable representation of a cross-section of the population throughout the country with rheumatic diseases. All potential sites are screened for clinical research experience and adherence to GCP (Good Clinical Practice) guidelines

Who may be able to join

  • Be at least 18 years of age or older.
  • Be able and willing to provide written consent for participation in the registry as well as Personally Identifiable Information (PII) that includes Full Name and Date of Birth at a minimum.
  • Have been diagnosed with rheumatoid arthritis by a rheumatologist.
  • Meet at least one of the following criteria:
  • Currently receiving an Eligible Medication** that was started within 365 days of the Enrollment Visit.
  • A temporary interruption of an Eligible Medication is allowed if the interruption in treatment lasted <180 days.
  • Prescribed or receiving the first dose of an Eligible Medication** on the day of the Enrollment Visit.
  • Diagnosed with RA within 365 days of the Enrollment Visit regardless of treatment regimen ("Early RA").

Who cannot join

  • The patient must not:
  • Have a diagnosis of Juvenile idiopathic arthritis (JIA), Psoriatic arthritis (PsA), Spondyloarthritis (SpA), Ankylosing spondylitis (AS), Systemic lupus erythematosus (SLE), or any other form of autoimmune inflammatory arthritis.
  • Be starting only a non-eligible medication, unless the patient was diagnosed with RA within 365 days of the Enrollment Visit. Non-eligible medications include conventional DMARDs - for example methotrexate, sulfasalazine, leflunomide, etc. - and including prednisone.
  • Be participating in or planning to participate in a double-blind randomized clinical trial of an RA drug. Of note, concurrent participation in another observational registry or open-label Phase 3b/4 trial is not excluded.
  • Early Follow-Up Visit Criteria
  • To be eligible for an early CorEvitas Follow-Up Visit that is conducted <150 days since the last registry visit, the following conditions must be met:
  • A follow-up set of questionnaires should always be completed whenever a registry subject is being prescribed or receiving the first dose of a new (different) Eligible Medication at a routine office visit. If this occurs less than 150 days from the previous visit at which CorEvitas questionnaires had been completed, it is considered an "Early Follow-Up Visit." The next anticipated visit that follow-up questionnaires would be completed would be calculated off the Early Follow-up Visit date (=>150 days). Prior use of an Eligible Medication does not exclude a patient from an Early Follow-Up visit.
  • Eligible Medications are biologics, biosimilars, and JAK-inhibitors FDA-approved for the treatment of RA. Prior use of an Eligible Medication does not exclude a patient from enrollment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • CorEvitas, LLC

    Waltham, Massachusetts, 02451

Other trials in United States

About this study

This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for RA in a cohort of patients cared for by rheumatologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Read the detailed description

The primary objective for this registry is to systematically collect and document use patterns, effectiveness, and safety of DMARDs (Disease Modifying Anti-Rheumatic Drugs), biologic agents, and any other treatments currently used in the management of RA.

The design is a prospective, non-interventional registry for patients with RA under the care of a rheumatologist. Longitudinal data are collected from both patients and their treating rheumatology providers during routine clinical encounters using a structured and standardized data collection method. The scope of data collection includes but is not limited to patient demographics, disease duration, medical history (including all prior and current treatments for RA), smoking status, alcohol use, disease activity and severity, pain, as well as other clinician- and patient-reported outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted safety outcomes. After the enrollment visit, RA patients and physicians will complete the follow-up questionnaires during regularly scheduled clinical encounters. The goal is to collect data from patients and providers at six month intervals. Adverse events may be volunteered spontaneously by the subject, or be discovered as a result of general questioning by the Investigator. During all CorEvitas related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.

Keywords
rheumatoid arthritis, psoriatic arthritis, disease registry
Medical subject headings
Arthritis, Rheumatoid, Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01402661
Study groupRoleWhat they receive
Rheumatoid ArthritisPts presenting to enrolling sites across the US are invited to enroll if eligible.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patterns, effectiveness, and safety of DMARDs, biologic agents and any other treatments currently used in the management of RA

    Measured: Data are collected on subjects for as long as they consent to remain in the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2011 (estimated)
  2. Study startFeb 2002
  3. Primary completionDec 2100 (estimated)
  4. Study completionDec 2100 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
91,758 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01402661
Sponsor's protocol ID
CorEvitas-RA-100
Status last verified
Sep 2025
First submitted
25 Jul 2011
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Litman HJ, Sheffield KM, Pugach O, Shan M, Lakin P, Cui ZL, Curtis SE, Johnston JA, Harrold LR. Applying Bias Correction Methods to Build Hybrid Controls Using Real-World Patients for a Phase IIb Randomized Controlled Trial of Baricitinib for Rheumatoid Arthritis. Pharm Stat. 2025 Jul-Aug;24(4):e70020. doi: 10.1002/pst.70020.

    PubMed 40493525

  • Harrold LR, Bingham CO, Pope JE, O'Brien J, Moore PC, Roberts-Toler C, Yu M, Sweet LL, Shelbaya A, Masri KR. Effectiveness of tofacitinib versus tumor necrosis factor inhibitors and in those receiving tofacitinib as different lines of therapy in patients with rheumatoid arthritis: results from the United States CorEvitas Rheumatoid Arthritis Registry. Clin Rheumatol. 2025 Feb;44(2):635-648. doi: 10.1007/s10067-024-07245-3. Epub 2024 Dec 20.

    PubMed 39707042

  • Pappas DA, Blachley T, Best JH, Zlotnick S, Reiss WG, Emeanuru K, Kremer JM. Durability of Response to Tocilizumab Therapy in Rheumatoid Arthritis: Data from the US-Based Corrona Rheumatoid Arthritis Registry. Rheumatol Ther. 2021 Mar;8(1):467-481. doi: 10.1007/s40744-021-00285-0. Epub 2021 Feb 25.

    PubMed 33630272

  • Pappas DA, Blachley T, Zlotnick S, Best J, Emeanuru K, Kremer JM. Methotrexate Discontinuation and Dose Decreases After Therapy With Tocilizumab: Results From the Corrona Rheumatoid Arthritis Registry. Rheumatol Ther. 2020 Jun;7(2):357-369. doi: 10.1007/s40744-020-00200-z. Epub 2020 Mar 30.

    PubMed 32232740

  • Pappas DA, Etzel CJ, Zlotnick S, Best J, Blachley T, Kremer JM. Patterns of Prednisone Use in Patients with Rheumatoid Arthritis Initiating Treatment with Tocilizumab in Routine US Clinical Practice. Rheumatol Ther. 2019 Sep;6(3):421-433. doi: 10.1007/s40744-019-0162-6. Epub 2019 Jun 25.

    PubMed 31240499

  • Mease PJ, Collier DH, Saunders KC, Li G, Kremer JM, Greenberg JD. Comparative effectiveness of biologic monotherapy versus combination therapy for patients with psoriatic arthritis: results from the Corrona registry. RMD Open. 2015 Dec 30;1(1):e000181. doi: 10.1136/rmdopen-2015-000181. eCollection 2015.

    PubMed 26819748

  • Harrold LR, Reed GW, Magner R, Shewade A, John A, Greenberg JD, Kremer JM. Comparative effectiveness and safety of rituximab versus subsequent anti-tumor necrosis factor therapy in patients with rheumatoid arthritis with prior exposure to anti-tumor necrosis factor therapies in the United States Corrona registry. Arthritis Res Ther. 2015 Sep 18;17(1):256. doi: 10.1186/s13075-015-0776-1.

    PubMed 26382589

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by CorEvitas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patterns, effectiveness, and safety of DMARDs, biologic agents and any other treatments currently used in the management of RA (time frame: Data are collected on subjects for as long as they consent to remain in the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01402661, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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