CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry

NCT01402661 | Enrolling By Invitation

• 1 other identifier: CorEvitas-RA-100
• Study Type: observational
• Target: 91,758
• Locations: 1 country
• Sites: 1

Brief 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. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; psoriatic arthritis; disease registry

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (1)

Rheumatoid Arthritis

Pts presenting to enrolling sites across the US are invited to enroll if eligible.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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:
• (A) Currently receiving an Eligible Medication\*\* that was started within 365 days of the Enrollment Visit.
• i. A temporary interruption of an Eligible Medication is allowed if the interruption in treatment lasted \<180 days.
• (B) Prescribed or receiving the first dose of an Eligible Medication\*\* on the day of the Enrollment Visit.
• (C) Diagnosed with RA within 365 days of the Enrollment Visit regardless of treatment regimen ("Early RA").

You may not qualify if:

• 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

Sponsors & Collaborators

• CorEvitas: lead
• University of Massachusetts, Worcester: collaborator
• University of Alabama at Birmingham: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

Location

Related Publications (7)

• 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.

  PMID: 40493525 DERIVED

• 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.

  PMID: 39707042 DERIVED

• 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.

  PMID: 33630272 DERIVED

• 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.

  PMID: 32232740 DERIVED

• 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.

  PMID: 31240499 DERIVED

• 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.

  PMID: 26819748 DERIVED

• 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.

  PMID: 26382589 DERIVED

Related Links

• CorEvitas home page:

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Joel Kremer, MD

  Center for Rheumatology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: February 1, 2002
• Primary Completion (Estimated): December 1, 2100
• Study Completion (Estimated): December 1, 2100
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)