An investigator-initiated double-blind, parallel-group randomised controlled trial of Methotrexate versus GOLimumab and Methotrexate in very early PsA using clinical and whole body MRI outcomes.
Phase IIIb. Early Psoriatic Arthritis. Investigator initiated, double-blind, randomized, placebo-controlled, two-armed, parallel-group, single centre trial. The Primary Objective is to assess whether the combination of golimumab with methotrexate and steroids is superior to standard care (MTX monotherapy plus steroids) in reducing clinical disease activity in patients with early, treatment naïve PsA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Methotrexate
Simponi
The Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom
Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks
The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.
Time frame: 24 weeks
Psoriatic Arthritis Disease Activity Score (PASDAS) at 12 Weeks.
The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.
Time frame: 12 weeks
Psoriatic Arthritis Disease Activity Score (PASDAS) at 36 Weeks.
The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.
Time frame: 36 weeks
Psoriatic Arthritis Disease Activity Score (PASDAS) at 52 Weeks.
The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.
Time frame: 52 weeks
Composite Psoriatic Disease Activity Index (CPDAI) at 12 Weeks.
The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.
Time frame: 12 weeks
Composite Psoriatic Disease Activity Index (CPDAI) at 24 Weeks.
The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.
Time frame: 24 weeks
Composite Psoriatic Disease Activity Index (CPDAI) at 36 Weeks.
The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 36 weeks
Composite Psoriatic Disease Activity Index (CPDAI) at 52 Weeks.
The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.
Time frame: 52 weeks
Participant Disease Activity Visual Analogue Score at 24 Weeks.
The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome.
Time frame: 24 weeks
Participant Disease Activity Visual Analogue Score at 52 Weeks.
The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome.
Time frame: 52 weeks
36-item Short Form Health Survey (SF-36) Physical Component Score at 24 Weeks.
The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome.
Time frame: 24 weeks
36-item Short Form Health Survey (SF-36) Physical Component Score at 52 Weeks.
The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome.
Time frame: 52 weeks
36-item Short Form Health Survey (SF-36) Mental Component Score at 24 Weeks.
The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome.
Time frame: 24 weeks
36-item Short Form Health Survey (SF-36) Mental Component Score at 52 Weeks.
The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome.
Time frame: 52 weeks
Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 12 Weeks.
In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.
Time frame: 12 weeks
Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 24 Weeks.
In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.
Time frame: 24 weeks
Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 36 Weeks.
In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.
Time frame: 36 weeks
Ultrasound Entheseal Inflammatory Score at 12 Weeks.
The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.
Time frame: 12 weeks
Ultrasound Entheseal Inflammatory Score at 24 Weeks.
The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.
Time frame: 24 weeks
Ultrasound Entheseal Inflammatory Score at 36 Weeks.
The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.
Time frame: 36 weeks
Ultrasound Entheseal Chronicity Score at 12 Weeks.
The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.
Time frame: 12 weeks
Ultrasound Entheseal Chronicity Score at 24 Weeks.
The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.
Time frame: 24 weeks
Ultrasound Entheseal Chronicity Score at 36 Weeks.
The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.
Time frame: 36 weeks
Leeds Enthesitis Index at 12 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Time frame: 12 Weeks
Leeds Enthesitis Index at 24 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Time frame: 24 Weeks
Leeds Enthesitis Index at 36 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Time frame: 36 Weeks
Leeds Enthesitis Index at 52 Weeks
The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.
Time frame: 52 Weeks
Leeds Dactylitis Index at 12 Weeks
The Leeds Dactylitis Index ranges from 0-\~40; a higher score represents a worse outcome.
Time frame: 12 Weeks
Leeds Dactylitis Index at 24 Weeks
The Leeds Dactylitis Index ranges from 0-\~40; a higher score represents a worse outcome.
Time frame: 24 Weeks
Leeds Dactylitis Index at 36 Weeks
The Leeds Dactylitis Index ranges from 0-\~40; a higher score represents a worse outcome.
Time frame: 36 Weeks
Leeds Dactylitis Index at 52 Weeks
The Leeds Dactylitis Index ranges from 0-\~40; a higher score represents a worse outcome.
Time frame: 52 Weeks
The Modified Nail Psoriasis Severity Index (mNAPSI) at 12 Weeks
The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.
Time frame: 12 Weeks
The Modified Nail Psoriasis Severity Index (mNAPSI) at 24 Weeks
The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.
Time frame: 24 Weeks
The Modified Nail Psoriasis Severity Index (mNAPSI) at 36 Weeks
The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.
Time frame: 36 Weeks
The Modified Nail Psoriasis Severity Index (mNAPSI) at 52 Weeks
The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.
Time frame: 52 Weeks
Psoriasis Area and Severity Index (PASI) Score at 12 Weeks
The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.
Time frame: 12 Weeks
Psoriasis Area and Severity Index (PASI) Score at 24 Weeks
The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.
Time frame: 24 Weeks
Psoriasis Area and Severity Index (PASI) Score at 36 Weeks
The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.
Time frame: 36 Weeks
Psoriasis Area and Severity Index (PASI) Score at 52 Weeks
The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.
Time frame: 52 Weeks
Dermatology Life Quality Index (DLQI) Score at 24 Weeks
The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome.
Time frame: 24 Weeks
Dermatology Life Quality Index (DLQI) Score at 52 Weeks
The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome.
Time frame: 52 Weeks
Minimal Disease Activity (MDA) at 12 Weeks
Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.
Time frame: 12 Weeks
Minimal Disease Activity (MDA) at 24 Weeks
Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.
Time frame: 24 Weeks
Minimal Disease Activity (MDA) at 36 Weeks
Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.
Time frame: 36 Weeks
Minimal Disease Activity (MDA) at 52 Weeks
Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.
Time frame: 52 Weeks
American College of Rheumatology 20 (ACR20) Response at 12 Weeks
American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 12 Weeks
American College of Rheumatology 20 (ACR20) Response at 24 Weeks
American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 24 Weeks
American College of Rheumatology 20 (ACR20) Response at 36 Weeks
American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 36 Weeks
American College of Rheumatology 20 (ACR20) Response at 52 Weeks
American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is: * 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 20% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 52 Weeks
American College of Rheumatology 50 (ACR50) Response at 12 Weeks
American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 12 Weeks
American College of Rheumatology 50 (ACR50) Response at 24 Weeks
American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 24 Weeks
American College of Rheumatology 50 (ACR50) Response at 36 Weeks
American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 36 Weeks
American College of Rheumatology 50 (ACR50) Response at 52 Weeks
American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is: * 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 50% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 52 Weeks
American College of Rheumatology 70 (ACR70) Response at 12 Weeks
American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 12 Weeks
American College of Rheumatology 70 (ACR70) Response at 24 Weeks
American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 24 Weeks
American College of Rheumatology 70 (ACR70) Response at 36 Weeks
American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 36 Weeks
American College of Rheumatology 70 (ACR70) Response at 52 Weeks
American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is: * 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and * 70% improvement in at least 3 of the following 5 ACR Core set criteria: 1. Patient's Assessment of Pain Visual Analogue Scale (VAS) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Patient's Assessment of Physical Function as measured by the HAQ-DI 5. Acute phase reactant as measured by CRP
Time frame: 52 Weeks
Psoriatic Arthritis Response Criteria (PsARC) Response at 12 Weeks
Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)
Time frame: 12 Weeks
Psoriatic Arthritis Response Criteria (PsARC) Response at 24 Weeks
Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)
Time frame: 24 Weeks
Psoriatic Arthritis Response Criteria (PsARC) Response at 36 Weeks
Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)
Time frame: 36 Weeks
Psoriatic Arthritis Response Criteria (PsARC) Response at 52 Weeks
Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: 1. At least 30% reduction in tender joint grade (total of 68 joints graded 0-3) 2. At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3) 3. At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale) 4. At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)
Time frame: 52 Weeks
Psoriatic Arthritis Skin Index (PASI) Response at 12 Weeks
Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.
Time frame: 12 Weeks
Psoriatic Arthritis Skin Index (PASI) Response at 24 Weeks
Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.
Time frame: 24 Weeks
Psoriatic Arthritis Skin Index (PASI) Response at 36 Weeks
Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.
Time frame: 36 Weeks
Psoriatic Arthritis Skin Index (PASI) Response at 52 Weeks
Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.
Time frame: 52 Weeks
Ultrasound Imaging Remission at 12 Weeks
Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\<=1 \& power Doppler=0.
Time frame: 12 Weeks
Ultrasound Imaging Remission at 24 Weeks
Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\<=1 \& power Doppler=0.
Time frame: 24 Weeks
Ultrasound Imaging Remission at 36 Weeks
Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale\<=1 \& power Doppler=0.
Time frame: 36 Weeks
Additional Steroid Received Before 24 Weeks
Participants were eligible for additional steroid at weeks 8 and 12 if they had not achieved a PsARC response; this variable was coded 0=No, 1=Yes.
Time frame: 12 Weeks