COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01932372
Recruitment Status : Active, not recruiting
First Posted : August 30, 2013
Last Update Posted : June 17, 2020
Information provided by (Responsible Party):

Brief Summary:

The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice.

1) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy 2) Long-term safety (particularly, malignant tumors and serious infections) and efficacy

Occurrences of malignant tumors and serious infections will be compared with a control group.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Tofacitinib (Xeljanz) Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc

Detailed Description:
All the patients whom an investigator prescribes the Xeljanz or Standard of Care for rheumatoid arthritis should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Layout table for study information
Study Type : Observational
Actual Enrollment : 10477 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : July 26, 2013
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Tofacitinib (Xeljanz)
Tablets 5 mg BID
Drug: Tofacitinib (Xeljanz)
5 mg Tablet BID

Standard of Care
Standard of Care for Rheumatoid Arthritis
Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly

Primary Outcome Measures :
  1. Disease Activity Score Based on 28-joints Count (DAS28) [ Time Frame: 24 months ]
    DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.

  2. Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: 36 months ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to over 8 mg Methotrexate for 3 months treatment.

Inclusion Criteria:

  • All patients receiving Tofacitinib (Xeljanz)

Exclusion Criteria:

Not Applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01932372

Layout table for location information
Tokyo, Japan
Sponsors and Collaborators
Layout table for investigator information
Study Director: Pfizer Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer Identifier: NCT01932372    
Other Study ID Numbers: A3921194
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at:
Keywords provided by Pfizer:
Rheumatoid Arthritis
Good Post Marketing Study Practice
Regulatory Post Marketing Commitment Plan
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action