leflunomide and Psoriasis Arthropathica

leflunomide has been researched along with Psoriasis Arthropathica in 51 studies

Leflunomide: An isoxazole derivative that inhibits dihydroorotate dehydrogenase, the fourth enzyme in the pyrimidine biosynthetic pathway. It is used an immunosuppressive agent in the treatment of RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.
leflunomide : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-methyl-1,2-oxazole-4-carboxylic acid with the anilino group of 4-(trifluoromethyl)aniline. The prodrug of teriflunomide.

Research

Studies (51)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Acute Phase C - Reactive Protein

"C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.~CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation.~Change from Baseline in C-Reactive Protein." (NCT02980692)
Timeframe: Week 52

Change From Baseline in Erythrocyte Sedimentation Rate

An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation. (NCT02980692)
Timeframe: Week 52

Change From Baseline in Health Assessment Questionnaire- Disability Index

"eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).~The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability" (NCT02980692)
Timeframe: Week 52

Change From Baseline in Leeds Dactylitis Index (LDI)

"tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)~Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score~Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45~The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.~Lower Leeds Dactylitis Index score represent better outcome." (NCT02980692)
Timeframe: Week 52

Change From Baseline in Leeds Enthesitis Index (LEI)

"The LEI examines tenderness at 6 sites:~2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.~Lower the score better is the outcome" (NCT02980692)
Timeframe: Week 52

Change From Baseline in Patient's Global Assessment of Disease Activity

"100 mm Visual analog scale descriptors (verbal) : very well (0) to very poorly(100)" (NCT02980692)
Timeframe: Week 52

Change From Baseline in Patient's Pain Assessment

"100 mm Visual Analog Scale with scale (verbal descriptors) no pain (0) to worst possible pain (100)." (NCT02980692)
Timeframe: Week 52

Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale

"100 mm Visual analog scale with descriptors (verbal) : very good (0) to very poor (100)" (NCT02980692)
Timeframe: Week 52

Change From Baseline in Swollen Joint Counts

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis. (NCT02980692)
Timeframe: Week 52

Change From Baseline in Tender Joint Counts

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis. (NCT02980692)
Timeframe: Week 52

Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate

"The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.~For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100." (NCT02980692)
Timeframe: week 24

Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate

"The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.~For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100." (NCT02980692)
Timeframe: week 52

The Proportion of Subjects Who Require Adjustment of Background Therapy

(NCT02980692)
Timeframe: Week 16

Acute Phase C - Reactive Protein

"C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.~CRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation" (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20, and week 24

Change From Baseline in Leeds Dactylitis Index (LDI)

"tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)~Total score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score~Standard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45~The difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.~Lower Leeds Dactylitis Index score represent better outcome." (NCT02980692)
Timeframe: week 4, week 12, and week 24

Change From Baseline in Leeds Enthesitis Index (LEI)

"The LEI examines tenderness at 6 sites:~2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.~Lower the score better is the outcome" (NCT02980692)
Timeframe: week 4, week 12 and week 24

Change From Baseline in Swollen Joint Counts

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis. (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20, and week 24

Change From Baseline in Tender Joint Counts

Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis. (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20, and week 24

Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate

"The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP).~DAS28-CRP(4) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health" (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and Week 52

Erythrocyte Sedimentation Rate

An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation. (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20, and week 24

Health Assessment Questionnaire- Disability Index

"eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).~The score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability" (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20, and week 24

Minimal Disease Activity

"A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria:~tender joint count ≤1;~swollen joint count ≤1;~PASI score ≤1 or BSA ≤3%;~patient Arthritis Pain (VAS)~≤15 mm;~patient's global arthritis assessment (VAS) ≤20 mm;~HAQ-DI score ≤0.5;~tender entheseal points (using LEI) ≤1." (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52

Patient's Global Assessment of Disease Activity

"100 mm Visual analog scale descriptors (verbal) : very well (0) to very poorly(100)" (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20 and week 24

Patient's Pain Assessment

"100 mm Visual Analog Scale with scale (verbal descriptors) no pain (0) to worst possible pain (100)." (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20, and week 24

Physician Global Assessment of Disease Activity Visual Analog Scale

"100 mm Visual analog scale with descriptors (verbal) : very good (0) to very poor (100)" (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20, and week 24

Proportion of Subjects Achieving American College of Rheumatology50 Response Rate

"The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.~For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100." (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52

Proportion of Subjects Achieving American College of Rheumatology70 Response Rate

"The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein.~For 'Units of Measure'- Data entered is proportion of participants, which is calculated by dividing the value obtained (percentage in this case) by 100." (NCT02980692)
Timeframe: week 1, week 4, week 8, week 12, week 16, week 20, week 24, and week 52

Reviews

14 reviews available for leflunomide and Psoriasis Arthropathica

Trials

8 trials available for leflunomide and Psoriasis Arthropathica

Other Studies

29 other studies available for leflunomide and Psoriasis Arthropathica