Rheumatoid ArthritisNCT01932372

Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

An observational study of Rheumatoid Arthritis, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 0 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Tofacitinib (Xeljanz) and Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
Type of treatment: Pill or oral medicine
How many people: 9,968 participants
Where: 1 siteJapan
Study dates: 26 Jul 2013to 24 Aug 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 0 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

All patients receiving Tofacitinib (Xeljanz)

Who cannot join

Not Applicable

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Tokyo

Other trials in Japan

About this study

Official title: XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)

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

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.

Read the 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.

Conditions: Rheumatoid Arthritis
Being tested: Tofacitinib (Xeljanz), Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
Keywords: Rheumatoid Arthritis, Good Post Marketing Study Practice, Tofacitinib, Xeljanz, Regulatory Post Marketing Commitment Plan
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

Tofacitinib (Xeljanz)Drug
5 mg Tablet BID
Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etcDrug
Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly

Study groups in NCT01932372
Study group	Role	What they receive
Tofacitinib (Xeljanz)		Tablets 5 mg BID Receives: Drug: Tofacitinib (Xeljanz)
Standard of Care		Standard of Care for Rheumatoid Arthritis Receives: Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc

What is being measured

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

Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious adverse event/adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician.
Measured: 36 months
Change in Disease Activity Based on Simplified Disease Activity Index (SDAI)
The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS, and C-reactive protein (CRP) (mg/dL). SDAI is defined as follows: ≤3.3, disease remission; >3.3 to ≤11, low disease activity, >11 to ≤26, moderate disease activity; and >26, high disease activity. SDAI was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.
Measured: Baseline, 1, 6, 12, 24, 36 months
Change in Disease Activity Score Based on 28-joints Count (DAS28)
DAS28 is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, PtGA assessed on 0-10 cm VAS, and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). DAS28 is defined as follows: <2.6, disease remission; ≥2.6 to <3.2, low disease activity, ≥3.2 to ≤5.1, moderate disease activity; and >5.1, high disease activity. DAS28 was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.
Measured: Baseline, 1, 6, 12, 24, 36 months

Secondary outcomes (3)

Occurrence of Serious Infection Events
Comparison of time to serious infection between XELJANZ group and control group.
Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensity score estimated by random forest (with upper limit of weighting)
Measured: 12 months
Occurrence of Malignancy
Comparison of time to malignancy between XELJANZ group and control group. The standard incidence ratio (SIR) was calculated using the general Japanese population as the reference population.
Hazard ratio (unadjusted): Baseline characteristics are unadjusted Hazard ratio (adjusted 1): Adjusted by propensity score estimated by logistic regression Hazard ratio (adjusted 2): Adjusted by propensity score estimated by random forest Hazard ratio (adjusted 3): Adjusted by propensity score estimated by logistic regression (with upper limit of weighting) Hazard ratio (adjusted 4): Adjusted by propensity score estimated by random forest (with upper limit of weighting)
Measured: 36 months
Occurrence of Death
Comparison of time to death between XELJANZ group and control group. The standardized mortality ratio (SMR) was calculated using the general Japanese population as the reference population.
Hazard ratio (unadjusted): Baseline characteristics are unadjusted
Measured: 36 months

Timeline

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

26 Jul 201324 Aug 2021

First posted30 Aug 2013 (estimated)
Study start26 Jul 2013
Primary completion24 Aug 2021
Study completion24 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 9,968 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01932372
Sponsor's protocol ID: A3921194
Status last verified: Jul 2024
First submitted: 30 Jul 2013
Last updated: 26 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: 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: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Kuwana M, Sugiyama N, Momohara S, Atsumi T, Takei S, Tamura N, Harigai M, Fujii T, Matsuno H, Takeuchi T, Yamamoto K, Takasaki Y, Tanigawa M, Endo Y, Hirose T, Morishima Y, Yoshii N, Mimori T, Takagi M. Six-month safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Interim analysis of post-marketing surveillance. Mod Rheumatol. 2024 Feb 26;34(2):272-286. doi: 10.1093/mr/road063.
PubMed 37405710

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)
ClinicalTrials.gov ID: NCT01932372
Acronym / sponsor ID: A3921194
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Good Post Marketing Study Practice, Tofacitinib, Xeljanz, Regulatory Post Marketing Commitment Plan
Study type: Observational
Recruitment status: Completed
Enrolment: 9,968 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 26 Jul 2013 (actual)
Primary completion: 24 Aug 2021 (actual)
Study completion: 24 Aug 2021 (actual)
First posted: 30 Aug 2013 (estimated)
Results: Posted 26 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Tofacitinib (Xeljanz)	–	Drug: Tofacitinib (Xeljanz)Tablets 5 mg BID
Standard of Care	–	Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etcStandard of Care for Rheumatoid Arthritis

Who may qualify

Ages: 0 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (1 listed)

All patients receiving Tofacitinib (Xeljanz)

Key exclusion criteria (1 listed)

Not Applicable

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tofacitinib (Xeljanz)5 mg Tablet BID	Drug	Tofacitinib (Xeljanz)
Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etcEtanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly	Drug	Standard of Care

Primary outcome

Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ
Time frame: 36 months
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious adverse event/adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician.
Change in Disease Activity Based on Simplified Disease Activity Index (SDAI)
Time frame: Baseline, 1, 6, 12, 24, 36 months
The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS, and C-reactive protein (CRP) (mg/dL). SDAI is defined as follows: ≤3.3, disease remission; >3.3 to ≤11, low disease activity, >11 to ≤26, moderate disease activity; and >26, high disease activity. SDAI was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.
Change in Disease Activity Score Based on 28-joints Count (DAS28)
Time frame: Baseline, 1, 6, 12, 24, 36 months
DAS28 is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, PtGA assessed on 0-10 cm VAS, and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). DAS28 is defined as follows: <2.6, disease remission; ≥2.6 to <3.2, low disease activity, ≥3.2 to ≤5.1, moderate disease activity; and >5.1, high disease activity. DAS28 was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.

3 secondary outcomes

Occurrence of Serious Infection Events
Time frame: 12 months
Occurrence of Malignancy
Time frame: 36 months
Occurrence of Death
Time frame: 36 months

Results and safety

Results posted to the registry on 26 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
XELJANZ (Safety Analysis Set)	7,054	7,021
Control (MTX Adherent Comparative Safety Analysis Set)	2,598	2,419

Primary outcome: Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ

Time frame: 36 months. Number. Unit: Percentage of Participants

Measure	XELJANZ (MTX Adherent Safety Analysis Set) n = 4574
ADR	41.60
Serious ADR	12.88

Population analysed: The MTX adherent safety analysis set (n=4574) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who did not meet the conditions to receive MTX, participated in a clinical trial, or transferred to another hospital.

Primary outcome: Change in Disease Activity Based on Simplified Disease Activity Index (SDAI)

Time frame: Baseline, 1, 6, 12, 24, 36 months. Mean (95% Confidence Interval). Unit: Scores on a scale

Measure	XELJANZ (MTX Adherent Efficacy Analysis Set) At 1 Month From Baseline n = 1937	XELJANZ (MTX Adherent Efficacy Analysis Set) At 6 Months From Baseline n = 2520	XELJANZ (MTX Adherent Efficacy Analysis Set) At 12 Months From Baseline n = 1661	XELJANZ (MTX Adherent Efficacy Analysis Set) At 24 Months From Baseline n = 1227	XELJANZ (MTX Adherent Efficacy Analysis Set) At 36 Months From Baseline n = 976
Value	-10.16 (-10.69 to -9.62)	-14.59 (-15.10 to -14.07)	-15.97 (-16.62 to -15.32)	-16.88 (-17.64 to -16.12)	-17.37 (-18.21 to -16.53)

Population analysed: The MTX adherent efficacy analysis set (n=4455) comprised of participants who received XELJANZ Tablets 5 mg at least once for the treatment of poorly controlled RA despite continuous use of MTX, excluding participants who were confirmed ineligible or not assessable for effectiveness. Of the 4455 MTX adherent efficacy analysis set, the participants with available results at each evaluation point are described.

Primary outcome: Change in Disease Activity Score Based on 28-joints Count (DAS28)

Time frame: Baseline, 1, 6, 12, 24, 36 months. Mean (95% Confidence Interval). Unit: Scores on a scale

Measure	XELJANZ (MTX Adherent Efficacy Analysis Set) At 1 Month From Baseline n = 1682	XELJANZ (MTX Adherent Efficacy Analysis Set) At 6 Months From Baseline n = 2119	XELJANZ (MTX Adherent Efficacy Analysis Set) At 12 Months From Baseline n = 1440	XELJANZ (MTX Adherent Efficacy Analysis Set) At 24 Months From Baseline n = 1074	XELJANZ (MTX Adherent Efficacy Analysis Set) At 36 Months From Baseline n = 852
Value	-0.98 (-1.04 to -0.92)	-1.52 (-1.58 to -1.46)	-1.67 (-1.75 to -1.59)	-1.82 (-1.91 to -1.73)	-1.86 (-1.96 to -1.76)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
XELJANZ (Safety Analysis Set)	1,351 of 7,021 (19.2%)	1,340 of 7,021 (19.1%)	188 of 7,021
XELJANZ (MTX Adherent Comparative Safety Analysis Set)	773 of 3,731 (20.7%)	814 of 3,731 (21.8%)	98 of 3,731
Control (MTX Adherent Comparative Safety Analysis Set)	112 of 2,419 (4.6%)	28 of 2,419 (1.2%)	16 of 2,419

Limitations and caveats (from the sponsor): According to the protocol, only three events, Serious Infection, Malignancy, and Death were collected in the control group for comparison with the Xeljanz group and other serious AEs or non-serious AEs were not to be collected although all AEs were collected in Xeljanz group. However several serious and non-serious AEs other than three events were incidentally reported by the investigators in the control group. Note that these AEs do not represent all AEs occurred in the control group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37405710Kuwana M, Sugiyama N, Momohara S, Atsumi T, Takei S, Tamura N, Harigai M, Fujii T, Matsuno H, Takeuchi T, Yamamoto K, Takasaki Y, Tanigawa M, Endo Y, Hirose T, Morishima Y, Yoshii N, Mimori T, Takagi M. Six-month safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Interim analysis of post-marketing surveillance. Mod Rheumatol. 2024 Feb 26;34(2):272-286. doi: 10.1093/mr/road063.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Pfizer at 1 site in Japan.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Oct 2024. 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 Japan. 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?

Yes. Results are posted in the registry (first posted 26 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ (time frame: 36 months). The study lists 3 primary outcomes in all. 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 NCT01932372, which also lists 1 linked publication.

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 26 Oct 2024.