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Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01932372
Recruitment Status : Active, not recruiting
First Posted : August 30, 2013
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

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Study Type : Observational
Actual Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tofacitinib Special Investigation Of Xeljanz Tablets 5mg. (Regulatory Post Marketing Commitment Plan)
Actual Study Start Date : July 26, 2013
Estimated Primary Completion Date : January 26, 2021
Estimated Study Completion Date : January 26, 2021

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.



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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.
Criteria

Inclusion Criteria:

  • All patients receiving Tofacitinib (Xeljanz)

Exclusion Criteria:


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 ClinicalTrials.gov identifier (NCT number): NCT01932372


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01932372     History of Changes
Other Study ID Numbers: A3921194
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Keywords provided by Pfizer:
Rheumatoid Arthritis
Good Post Marketing Study Practice
Tofacitinib
Xeljanz
Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Antirheumatic Agents
Tofacitinib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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