Trial · NCT02889796
Registered outcomes80
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 80
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 | Week 12 | ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 (0 and 100 indicating no disease activity and maximum disease activity)participant's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain) health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions,8 components: dressing/ grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders. |
| Secondary | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 | Baseline; Week 12 | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability). |
| Secondary | Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12 | Week 12 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP (CRP = hsCRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. |
| Secondary | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Baseline; Week 24 | Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range \[0-448\]) is defined as the erosion score (range \[0-280\]) plus the joint space narrowing (JSN) score (range \[0-168\]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal joint spaces). |
| Secondary | Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12 | Week 12 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. |
| Secondary | Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 | Baseline; Week 12 | The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. |
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 | Baseline; Week 12 | FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue). |
| Secondary | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 | Weeks 2, 4, 12, and 24 | ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Secondary | Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 | Weeks 36, and 52 | ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Secondary | Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 | Weeks 2, 4, 12, and 24 | ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Secondary | Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 | Weeks 36, and 52 | ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Secondary | Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 | Weeks 2, 4, and 24 | ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Secondary | Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 | Weeks 36, and 52 | ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders. |
| Secondary | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 | Baseline; Weeks 2, 4, and 24 | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 | Baseline; Weeks 2, 4, 12, and 24 | TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 | Baseline; Weeks 2, 4, 12, and 24 | The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 | Baseline; Weeks 36, and 52 | The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 | Baseline; Weeks 2, 4, 12, and 24 | SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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)
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