Trial · NCT05576051
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.
NCT05576051, Completed, Pfizer; results first posted 2025-12-23
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. 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. Trials, record NCT05576051. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05576051
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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.
- NCT number
- NCT05576051
- Status
- Completed
- Enrollment
- 9,159 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Rheumatoid Arthritis
- Interventions
- patterns of use of combination therapy and monotherapy
- First posted
- 2022-10-12
- Last updated
- 2025-12-23
- Results first posted
- 2025-12-23
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) | 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. |
| Secondary | CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX | 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. |
| Secondary | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | 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. |
| Secondary | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy | 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. |
| Secondary | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX | 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. |
| Secondary | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | 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. |
| Secondary | Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX | At month 6 follow up visit | 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). |
| Secondary | Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX | At month 6 follow up visit | 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). |
| Secondary | Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | At month 6 follow up visit | 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). |
| Secondary | Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | At month 6 follow up visit | 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). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) | At month 6 follow up visit | 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. | Units on a scale | MEAN |
| SECONDARY | CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX | At month 6 follow up visit | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, n signifies number of participants evaluable for specified rows. Due to change in planned analysis, data for TNFi initiators after 11/6/2012 combination and monotherapy arms were not evaluable for CDAI score outcome measure as CDAI score data were not available in medical records for any participant in TNFi initiators after 11/6/2012 combination and monotherapy arms. | Units on a scale | MEAN |
| SECONDARY | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | At month 6 follow up visit | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy | At month 6 follow up visit | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX | At month 6 follow up visit | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | At month 6 follow up visit | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows. | Units on a scale | MEAN |
| SECONDARY | Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX | At month 6 follow up visit | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed (N) signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX | At month 6 follow up visit | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, N signifies number of participants evaluable for this outcome measure. Due to change in planned analysis, data for TNFi initiators after 11/6/2012 combination and monotherapy arms were not evaluable for mACR20 outcome measure as mACR20 data were not available in medical records for any participant in TNFi initiators after 11/6/2012 combination and monotherapy arms. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | At month 6 follow up visit | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | At month 6 follow up visit | Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) | Tofacitinib Initiators Combination | All | 18.1 | Standard Deviation 15.1 | Units on a scale |
| Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) | Tofacitinib Initiators Monotherapy | All | 17 | Standard Deviation 13.4 | Units on a scale |
| Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) | Tofacitinib Initiators Combination | Non-switchers | 16.6 | Standard Deviation 14.3 | Units on a scale |
| Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) | Tofacitinib Initiators Monotherapy | Non-switchers | 14.6 | Standard Deviation 11.6 | Units on a scale |
| CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX | All TNFi Initiators Combination | All | 13.9 | Standard Deviation 12.5 | Units on a scale |
| CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX | All TNFI Initiators Monotherapy | All | 16.5 | Standard Deviation 13.8 | Units on a scale |
| CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX | All TNFi Initiators Combination | Non-switchers | 13 | Standard Deviation 11.8 | Units on a scale |
| CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX | All TNFI Initiators Monotherapy | Non-switchers | 14.9 | Standard Deviation 13 | Units on a scale |
| CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | All TNFi Initiators Combination | All | 13.9 | Standard Deviation 12.5 | Units on a scale |
| CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | Tofacitinib Initiators Monotherapy | All | 17 | Standard Deviation 13.4 | Units on a scale |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Tumor Necrosis Factor Inhibitor (TNFi) Initiators Combination | 5,077 | |
| Overall Study | STARTED | All TNFi Initiators Monotherapy | 2,275 | |
| Overall Study | STARTED | TNFi Initiators After 11/6/2012 Combination | 987 | |
| Overall Study | STARTED | TNFi Initiators After 11/6/2012 Monotherapy | 494 | |
| Overall Study | STARTED | Tofacitinib Initiators Combination | 124 | |
| Overall Study | STARTED | Tofacitinib Initiators Monotherapy | 202 | |
| Overall Study | COMPLETED | All Tumor Necrosis Factor Inhibitor (TNFi) Initiators Combination | 4,215 | |
| Overall Study | COMPLETED | All TNFi Initiators Monotherapy | 1,724 | |
| Overall Study | COMPLETED | TNFi Initiators After 11/6/2012 Combination | 825 | |
| Overall Study | COMPLETED | TNFi Initiators After 11/6/2012 Monotherapy | 394 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All TNFi Initiators Combination | 0 | 0 |
| Total, all-cause mortality | All TNFi Initiators Monotherapy | 0 | 0 |
| Total, all-cause mortality | TNFi Initiators After 11/6/2012 Combination | 0 | 0 |
| Total, all-cause mortality | TNFi Initiators After 11/6/2012 Monotherapy | 0 | 0 |
| Total, all-cause mortality | Tofacitinib Initiators Combination | 0 | 0 |
| Total, all-cause mortality | Tofacitinib Initiators Monotherapy | 0 | 0 |
| Total, other adverse events | All TNFi Initiators Combination | 0 | 0 |
| Total, other adverse events | All TNFi Initiators Monotherapy | 0 | 0 |
| Total, other adverse events | TNFi Initiators After 11/6/2012 Combination | 0 | 0 |
| Total, other adverse events | TNFi Initiators After 11/6/2012 Monotherapy | 0 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| All TNFi Initiators Combination vs Tofacitinib Initiators Monotherapy: Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | Trial comparisons |
| All TNFI Initiators Monotherapy vs Tofacitinib Initiators Monotherapy: Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | Trial comparisons |
| All TNFI Initiators Monotherapy vs Tofacitinib Initiators Combination: Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy | Trial comparisons |
Tofacitinib Initiators Combination vs Tofacitinib Initiators Monotherapy: Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX | Trial comparisons |
| All TNFi Initiators Combination vs Tofacitinib Initiators Combination: Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX | Trial comparisons |
| All TNFi Initiators Combination vs All TNFI Initiators Monotherapy: Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05576051
GET https://conductscience.org/api/trials/v1/NCT05576051/registered?page=2