Trial · NCT01976364
Registered outcomes75
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 75
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Treatment-emergent were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. |
| Primary | Number of Adverse Events (AEs) by Severity | Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function). |
| Primary | Number of Participants With Abnormal Clinical Laboratory Values | Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) | Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin \[total, direct, indirect\], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein \[A-1, B\]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria. |
| Primary | Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values | Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study) | Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin\[total,direct,indirect\], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein \[A-1, B\]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria. |
| Primary | Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6 | Sub-study: Baseline (Day 1), Month 6 | HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities. |
| Primary | Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 | Sub-study: Baseline (Day 1), Month 6 | PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease. |
| Secondary | Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response | Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Participants with 20% improvement from baseline in tender and swollen joint counts and 20% improvement in at least 3 of the 5 measures: Patient's global assessment of arthritis (PtGA), Physician's global assessment of arthritis (PhyGA), participant's assessment of arthritis pain, HAQ-DI and C-reactive protein (CRP) in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. |
| Secondary | Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response | Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Participants with 50% improvement from baseline in tender and swollen joint counts and 50% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. |
| Secondary | Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response | Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Participants with 70% improvement from baseline in tender and swollen joint counts and 70% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. |
| Secondary | Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities. |
| Secondary | Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) | Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | PsARC is comprised of 4 clinical improvement criteria: greater than or equal to (\>=) 20% improvement in PhyGA (VAS), \>=20% improvement in PtGA; and \>= 30% reduction in the number of tender joints; and \>=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen. |
| Secondary | Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | The PGA-PsO was a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe). |
| Secondary | Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | PASI: combined assessment of lesion severity and body area affected into single score; range =0 (no disease) -72 (maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0 (0%) - 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1 =slight, 2 =moderate, 3 =marked, 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: at least a 75 % reduction in PASI relative to Baseline. |
| Secondary | Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) \& severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 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). |
| Secondary | Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | PASI: combined assessment of lesion severity \& area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of clinical sign components for erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) and severity estimated by clinical signs components for erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 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). |
| Secondary | Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis severity score for a participant was 0-60. Higher score indicated greater severity. |
| Secondary | Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis. |
| Secondary | Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | The SPARCC enthesitis index identifies the presence or absence of tenderness at 16 enthesial sites, including (right and left): medial epicondyle humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle, Achilles tendon insertion into calcaneum and plantar fascia insertion into calcaneum. On examination, tenderness was recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicated a greater number of sites that are affected by enthesitis. |
| Secondary | Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 centimeter (cm) with higher score represented more severe ankylosing spondylitis disease activity. |
| Secondary | Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 | BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 cm with higher score represented more severe ankylosing spondylitis disease activity. |
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
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- 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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