Trial · NCT02486302
Registered outcomes52
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 52
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 | Week 12 | Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/h\]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale \[VAS\] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 \<2.6 = remission, DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Primary | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 | Week 24 | DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Primary | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks | Week 12 up to Week 52 | DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Primary | Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks | Week 24 up to Week 52 | DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR \[mm/h\] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Primary | Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 | Week 12 | PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect). |
| Primary | Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 | Week 12 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS. |
| Primary | Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 | Week 12 | DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC \<=1; 2) SJC =\<1; 3) PASI \<= 1 or body surface area (BSA) \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) \<= 0.5(HAQ=3.16-\[0.028\* hannover functional questionnaire \[FFbH\]); 7) Tender enthesial points \<= 1. |
| Primary | Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24 | Week 24 | PASI:combined assessment of lesion severity \& area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored \& scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) \& severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:\>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear \& almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect). |
| Primary | Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 | Week 24 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 \<= ASDAS \< 1.3; moderate disease activity: 1.3 \<= ASDAS \< 2.1; high disease activity: 2.1 \<= ASDAS \<= 3.5; very high disease activity: 3.5 \< ASDAS. |
| Primary | Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 | Week 24 | DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t\<=1; 2) SJC =\<1; 3) PASI \<= 1 or BSA \<=3; 4) Participant pain on VAS \<= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain \[best\] and 100 mm = maximum possible pain \[worst\]; 5) PtGA on VAS \<= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI \<= 0.5(HAQ=3.16-\[0.028\*FFbH); 7) Tender enthesial points \<= 1. |
| Secondary | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) | Baseline up to Weeks 12, 24, 36, 52 | |
| Secondary | Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Baseline up to Weeks 12, 24, 36, 52 | |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set | Baseline up to Weeks 12, 24, 36, 52 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set | Baseline up to Weeks 12, 24, 36, 52 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs. |
| Secondary | Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28\<2.6 = remission, DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 \<= 2.6 were considered in remission. |
| Secondary | Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | Participants answered question: "How do you assess your current disease activity?" Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity. |
| Secondary | Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. |
| Secondary | Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). |
| Secondary | Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity. |
| Secondary | Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 | Weeks 12, 24, 36, 52 | The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- 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)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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