To Estimate the Efficacy of Treatment With TNFi as Monotherapy or Combination Therapy With MTX and Compare and Contrast Efficacy With Tofacitinib as Monotherapy and Combination Therapy in a Real World Setting.

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

Completed

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

Trial summary

To estimate the efficacy of treatment with TNFi as monotherapy or combination therapy with MTX and compare and contrast efficacy with Tofacitinib as monotherapy and combination therapy in a real world setting. Read more about this study

Who is it for?: Any age
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: patterns of use of combination therapy and monotherapy
How many people: 9,159 participants
Where: 1 siteUnited States
Study dates: 4 Jun 2015to 7 Oct 2015
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Observational retrospective data using the Corrona RA Registry

Who may be able to join

RA patients in Corrona initiating a TNFi biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) during follow-up in Corrona with no prior use of Tofacitinib

Who cannot join

Patients with no history of cDMARD but history of 1+ biologics - these cases will be excluded from analyses
Patients using combination therapy with a cDMARD other than MTX will be excluded
Patients using combination therapy of MTX and another cDMARD will be excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer
New York, New York, 10017

Other trials in United States

About this study

Official title: Epidemiology and Efficacy of TNFi Combination Therapy (MTX+TNFi), TNFi Monotherapy, Tofacitinib Combination Therapy and Tofacitinib Monotherapy

Conditions: Rheumatoid Arthritis
Being tested: patterns of use of combination therapy and monotherapy
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

patterns of use of combination therapy and monotherapyOther

Study groups in NCT05576051
Study group	Role	What they receive
All TNFi initiations		Not described Receives: Other: patterns of use of combination therapy and monotherapy
TNFi initiations after 11/6/2012 for comparisons with Tofacitinib initiators		Not described Receives: Other: patterns of use of combination therapy and monotherapy
RA patient in Corrona with initiation Tofacitinib during follow-up in Corron		Not described Receives: Other: patterns of use of combination therapy and monotherapy

What is being measured

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

Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX)
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Measured: At month 6 follow up visit

Secondary outcomes (20)

CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Measured: At month 6 follow up visit
CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Measured: At month 6 follow up visit
CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Measured: At month 6 follow up visit
CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Measured: At month 6 follow up visit
CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Measured: At month 6 follow up visit
Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX
mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Measured: At month 6 follow up visit
Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX
mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Measured: At month 6 follow up visit
Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX
mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Measured: At month 6 follow up visit
Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy
mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Measured: At month 6 follow up visit
Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX
mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Measured: At month 6 follow up visit
Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy
mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Measured: At month 6 follow up visit
Number of Participants According to Line of Therapy at TNFi Initiation
Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of 1st line, 2nd line, 3rd line, and 4th line of therapy was reported in this outcome measure.
Measured: At baseline
Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012
Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at TNFi initiation after 11/6/2012 was reported in this outcome measure.
Measured: At baseline
Number of Participants According to Line of Therapy at Tofacitinib Initiation
Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at tofacitinib initiation was reported in this outcome measure.
Measured: At baseline
Median CDAI Score at Baseline- TNFi Initiator
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi Initiator.
Measured: At baseline
Median CDAI Score at Baseline- Tofacitinib Initiator
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of Tofacitinib Initiator.
Measured: At baseline
Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi initiator after 11-6-2012.
Measured: At baseline
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at TNFi initiation was reported in this outcome measure. Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics.
Measured: At baseline
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy (LOT): prior use of at least one biologic) use at TNFi initiation after 11/6/2012 was reported in this outcome measure.
Measured: At baseline
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at tofacitinib initiation was reported in this outcome measure.
Measured: At baseline

Timeline

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

4 Jun 20157 Oct 2015

First posted12 Oct 2022
Study start4 Jun 2015
Primary completion7 Oct 2015
Study completion7 Oct 2015

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.
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: Retrospective
Enrolment: 9,159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05576051
Sponsor's protocol ID: A3921422
Status last verified: Dec 2025
First submitted: 7 Oct 2022
Last updated: 23 Dec 2025
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.

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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epidemiology and Efficacy of TNFi Combination Therapy (MTX+TNFi), TNFi Monotherapy, Tofacitinib Combination Therapy and Tofacitinib Monotherapy
ClinicalTrials.gov ID: NCT05576051
Acronym / sponsor ID: A3921422
Conditions: Rheumatoid Arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 9,159 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 4 Jun 2015 (actual)
Primary completion: 7 Oct 2015 (actual)
Study completion: 7 Oct 2015 (actual)
First posted: 12 Oct 2022 (actual)
Results: Posted 23 Dec 2025

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
All TNFi initiations	–	Other: patterns of use of combination therapy and monotherapy
TNFi initiations after 11/6/2012 for comparisons with Tofacitinib initiators	–	Other: patterns of use of combination therapy and monotherapy
RA patient in Corrona with initiation Tofacitinib during follow-up in Corron	–	Other: patterns of use of combination therapy and monotherapy

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Observational retrospective data using the Corrona RA Registry

Key inclusion criteria (1 listed)

RA patients in Corrona initiating a TNFi biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) during follow-up in Corrona with no prior use of Tofacitinib

Key exclusion criteria (3 listed)

Patients with no history of cDMARD but history of 1+ biologics - these cases will be excluded from analyses
Patients using combination therapy with a cDMARD other than MTX will be excluded
Patients using combination therapy of MTX and another cDMARD will be excluded

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
patterns of use of combination therapy and monotherapy	Other	All TNFi initiations, RA patient in Corrona with initiation Tofacitinib during follow-up in Corron, TNFi initiations after 11/6/2012 for comparisons with Tofacitinib initiators

Primary outcome

Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX)
Time frame: At month 6 follow up visit
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.

20 secondary outcomes

CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX
Time frame: At month 6 follow up visit
CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX
Time frame: At month 6 follow up visit
CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy
Time frame: At month 6 follow up visit
CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX
Time frame: At month 6 follow up visit
CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy
Time frame: At month 6 follow up visit
Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX
Time frame: At month 6 follow up visit
Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX
Time frame: At month 6 follow up visit
Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX
Time frame: At month 6 follow up visit
Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy
Time frame: At month 6 follow up visit
Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX
Time frame: At month 6 follow up visit
Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy
Time frame: At month 6 follow up visit
Number of Participants According to Line of Therapy at TNFi Initiation
Time frame: At baseline
Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012
Time frame: At baseline
Number of Participants According to Line of Therapy at Tofacitinib Initiation
Time frame: At baseline
Median CDAI Score at Baseline- TNFi Initiator
Time frame: At baseline
Median CDAI Score at Baseline- Tofacitinib Initiator
Time frame: At baseline
Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012
Time frame: At baseline
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Time frame: At baseline
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Time frame: At baseline
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Time frame: At baseline

Results and safety

Results posted to the registry on 23 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Tumor Necrosis Factor Inhibitor (TNFi) Initiators Combination	5,077	4,215
All TNFi Initiators Monotherapy	2,275	1,724
TNFi Initiators After 11/6/2012 Combination	987	825
TNFi Initiators After 11/6/2012 Monotherapy	494	394
Tofacitinib Initiators Combination	124	86
Tofacitinib Initiators Monotherapy	202	147

Primary outcome: Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX)

Time frame: At month 6 follow up visit. Mean (Standard Deviation). Unit: Units on a scale

Measure	Tofacitinib Initiators Combination n = 96	Tofacitinib Initiators Monotherapy n = 145
All	18.1 (15.1)	17 (13.4)
Non-switchers	16.6 (14.3)	14.6 (11.6)

Population analysed: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Number Analyzed (n)" signifies number of participants evaluable for specified rows.

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Not applicable as adverse events and all-cause mortality were not planned to be evaluated for the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
All TNFi Initiators Combination	0 of 0	0 of 0
All TNFi Initiators Monotherapy	0 of 0	0 of 0
TNFi Initiators After 11/6/2012 Combination	0 of 0	0 of 0
TNFi Initiators After 11/6/2012 Monotherapy	0 of 0	0 of 0
Tofacitinib Initiators Combination	0 of 0	0 of 0
Tofacitinib Initiators Monotherapy	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 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 1 inclusion and 3 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 23 Dec 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?

Yes. Results are posted in the registry (first posted 23 Dec 2025). 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?

Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) (time frame: At month 6 follow up visit). 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 NCT05576051.

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 23 Dec 2025.