Trial · NCT05576051
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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). |
| Secondary | Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX 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 Combination With MTX 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). |
| Secondary | Number of Participants According to Line of Therapy at TNFi Initiation | At baseline | 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. |
| Secondary | Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | At baseline | 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. |
| Secondary | Number of Participants According to Line of Therapy at Tofacitinib Initiation | At baseline | 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. |
| Secondary | Median CDAI Score at Baseline- TNFi Initiator | At baseline | 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. |
| Secondary | Median CDAI Score at Baseline- Tofacitinib Initiator | At baseline | 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. |
| Secondary | Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012 | At baseline | 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. |
| Secondary | 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 | 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 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. |
| Secondary | 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 | At baseline | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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