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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00420927
Registration number
NCT00420927
Ethics application status
Date submitted
9/01/2007
Date registered
11/01/2007
Date last updated
18/04/2012
Titles & IDs
Public title
Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis
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Scientific title
A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)
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Secondary ID [1]
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0
2006-004139-31
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Secondary ID [2]
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M06-810
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Universal Trial Number (UTN)
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Trial acronym
OPTIMA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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0
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Osteoarthritis
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - adalimumab
Treatment: Drugs - methotrexate
Other interventions - placebo
Experimental: ADA+MTX/PBO+MTX (Arm 1) - Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
Experimental: ADA+MTX/ADA+MTX (Arm2) - Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
Experimental: ADA+MTX/OL ADA+MTX (Arm 3) - Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA + MTX during Period 2
Experimental: PBO+MTX/PBO+MTX (Arm 4) - Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
Experimental: PBO+MTX/OL ADA+MTX (Arm 5) - Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2.
Other interventions: adalimumab
Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
Treatment: Drugs: methotrexate
Methotrexate 2.5 mg tablets administered orally once a week starting at 7.5 mg/week with dose escalation (weekly or every other week) by 2.5 mg intervals to 20 mg/week.
Other interventions: placebo
Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4
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Assessment method [1]
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The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.
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Timepoint [1]
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Week 78
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Secondary outcome [1]
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Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 1
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Assessment method [1]
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The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.
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Timepoint [1]
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Week 78
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Secondary outcome [2]
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Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78
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Assessment method [2]
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The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.
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Timepoint [2]
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Week 78
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Secondary outcome [3]
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Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78
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Assessment method [3]
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The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.
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Timepoint [3]
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Week 78
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Secondary outcome [4]
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Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78
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Assessment method [4]
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For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
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Timepoint [4]
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Week 78
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Secondary outcome [5]
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Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78
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Assessment method [5]
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Subjects were responders if they had greater than or equal to 20% improvement in tender joint count; greater than or equal to 20% improvement in swollen joint count; and greater than or equal to 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).
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Timepoint [5]
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Week 78
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Secondary outcome [6]
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Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78
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Assessment method [6]
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Subjects were responders if they had: greater than or equal to 50% improvement in tender joint count; greater than or equal to 50% improvement in swollen joint count; and greater than or equal to 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).
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Timepoint [6]
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Week 78
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Secondary outcome [7]
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Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78
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Assessment method [7]
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Subjects were responders if they had: greater than or equal to 70% improvement in tender joint count; greater than or equal to 70% improvement in swollen joint count; and greater than or equal to 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).
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Timepoint [7]
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Week 78
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Secondary outcome [8]
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Change From Baseline in DAS28 Score at Week 78
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Assessment method [8]
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The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.
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Timepoint [8]
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Baseline to Week 78
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Secondary outcome [9]
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Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78
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Assessment method [9]
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The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.
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Timepoint [9]
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Week 78
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Secondary outcome [10]
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Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78
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Assessment method [10]
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The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.
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Timepoint [10]
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Week 78
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Secondary outcome [11]
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Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78
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Assessment method [11]
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The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.
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Timepoint [11]
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Week 78
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Secondary outcome [12]
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Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78
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Assessment method [12]
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The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.
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Timepoint [12]
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Week 78
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Secondary outcome [13]
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Change From Baseline in CDAI Score at Week 78
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Assessment method [13]
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The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.
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Timepoint [13]
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Baseline to Week 78
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Secondary outcome [14]
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Change From Baseline in SDAI Score at Week 78
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Assessment method [14]
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The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.
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Timepoint [14]
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Baseline to Week 78
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Secondary outcome [15]
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Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78
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Assessment method [15]
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Synovitis was assessed using high-field magnetic resonance imaging (MRI) of the hand and wrist. Images were read and scored according to the Outcomes Measures in Rheumatology Clinical Trials' Rheumatoid Arthritis MRI Scoring System (OMERACT RAMRIS). Synovitis in the wrist and finger joints in the most affected hand was scored from 0 (normal) to 3 (severe), for a maximum total score of 21.
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Timepoint [15]
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Baseline to Week 78
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Secondary outcome [16]
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Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5) and Normal Function (HAQ-DI Less Than 0.5) at Week 78
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Assessment method [16]
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In the Health Assessment Questionnaire Disability Index (HAQ-DI), participants rated their ability to perform daily tasks on a scale of 0 (without any difficulty) to 3 (unable to do). A mean score of 0-1 represents mild to moderate functional disability, 1-2 represents moderate to severe, 2-3 severe to very severe disability. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.
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Timepoint [16]
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Week 78
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Secondary outcome [17]
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Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than or Equal to 0.5), and ACR70 Response at Week 78
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Assessment method [17]
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In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (worst joint damage). American College of Rheumatology 70% (ACR70) response indicates at least 70% improvement in tender and swollen joint counts and at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; HAQ-DI; and C-reactive protein.
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Timepoint [17]
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Week 78
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Secondary outcome [18]
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Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than 0.5), and DAS28 Remission (DAS28 Less Than 2.6) at Week 78
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Assessment method [18]
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In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (severe joint damage). The Disease Activity Score (DAS28) ranges from 0.49 to 9.07, with scores less than 2.6 indicating clinical remission.
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Timepoint [18]
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Week 78
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Eligibility
Key inclusion criteria
Inclusion Criteria
- Subject must be 18 or older and in good health
- Subject must meet the definition of early rheumatoid arthritis (RA) defined by the
1987-revised American College of Rheumatology (ACR) classification criteria and had
disease duration of less than 1 year from diagnosis
- Subject must have a Disease Activity Score (DAS28, based on C-reactive protein)
greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8
tender joints out of the 68 assessed
- Subject must fulfill at least one of the following three criteria:
- Rheumatoid factor positive
- Greater than 1 joint erosion
- Anti-cyclic citrullinated peptide (CCP) antibody positive.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
- Subject has previously received systemic anti-tumor necrosis factor (TNF) therapy
- Subject has received any biologic or investigational therapy within 6 weeks prior to
Baseline
- Subject has been previously treated with more than 2 disease-modifying antirheumatic
drugs (DMARDs) or MTX, had been treated with intra-articular or parenteral
administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery
within the preceding 2 months at joints to be assessed during the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2010
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Sample size
Target
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Accrual to date
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Final
1032
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Site Reference ID/Investigator# 8380 - Campsie, Sydney
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Recruitment hospital [2]
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Site Reference ID/Investigator# 6954 - Clayton
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Recruitment hospital [3]
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Site Reference ID/Investigator# 6940 - Malvern East
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Recruitment postcode(s) [1]
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2194 - Campsie, Sydney
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3145 - Malvern East
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Alabama
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0
0
United States of America
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California
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0
United States of America
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Colorado
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0
United States of America
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Florida
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0
0
United States of America
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Idaho
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0
0
United States of America
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0
Illinois
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0
0
United States of America
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State/province [7]
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Kansas
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0
0
United States of America
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Maryland
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0
0
United States of America
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Massachusetts
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0
0
United States of America
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New Hampshire
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0
0
United States of America
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New Jersey
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0
0
United States of America
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New Mexico
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United States of America
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New York
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0
United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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0
United States of America
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Tennessee
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0
United States of America
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Texas
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United States of America
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Washington
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United States of America
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Wisconsin
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0
0
Argentina
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0
Buenos Aires
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0
Argentina
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Quilmes
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0
0
Argentina
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State/province [24]
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0
San Miguel de Tucuman
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Austria
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Graz
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Austria
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Vienna
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0
0
Belgium
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Brussels
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0
0
Belgium
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Genk
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Belgium
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Gilly
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Belgium
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Liege
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Belgium
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Mechelen
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Belgium
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Sint-Niklaas
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Belgium
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Yvoir
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Canada
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Burlington
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Canada
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Edmonton
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Canada
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Halifax
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Canada
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Hamilton
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Canada
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Montreal
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Canada
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Ottawa
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Canada
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Richmond
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Canada
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Sainte-Foy, Quebec
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Canada
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Sarnia
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Canada
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St. John's
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Canada
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Toronto
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Canada
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Victoria
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Canada
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Windsor
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Canada
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Winnipeg
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0
0
Czech Republic
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Brno
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0
Czech Republic
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Hradec Kralove
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0
0
Czech Republic
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Ostrava
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0
0
Czech Republic
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Prague 2
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Czech Republic
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0
Uherske Hradiste
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France
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0
Amiens
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0
0
France
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Le Mans
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0
0
France
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0
Paris Cedex 14
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0
0
France
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0
Strasbourg
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0
0
Germany
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0
Bad Nauheim
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0
0
Germany
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State/province [58]
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0
Berlin-Buch
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Country [59]
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0
Germany
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State/province [59]
0
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Damp
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Country [60]
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0
Germany
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State/province [60]
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Duesseldorf
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Country [61]
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Germany
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State/province [61]
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Frankfurt/Main
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Country [62]
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Germany
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State/province [62]
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Frankfurt
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Country [63]
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Germany
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State/province [63]
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Freiburg
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Country [64]
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Germany
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State/province [64]
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Halle
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Country [65]
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Germany
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Hofheim
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Country [66]
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Germany
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Munich
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Country [67]
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Germany
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Osnabrueck
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Country [68]
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Germany
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Ratingen
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Country [69]
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Germany
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Vogelsang-Gommern
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Country [70]
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Germany
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State/province [70]
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Zerbst
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Country [71]
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Hungary
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Budapest
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Country [72]
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Hungary
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State/province [72]
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Debrecen
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Country [73]
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Mexico
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Aguascallentes
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Mexico
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Leon, Guanajuato
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Country [75]
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Mexico
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State/province [75]
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Mexico City
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Country [76]
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Netherlands
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Arnem
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Country [77]
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Netherlands
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Hilversum
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Country [78]
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New Zealand
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State/province [78]
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Auckland 6
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Country [79]
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New Zealand
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Hamilton
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Country [80]
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New Zealand
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Timaru
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New Zealand
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Wellington
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Country [82]
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Norway
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State/province [82]
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Alesund
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Norway
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Kristiansand S
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Country [84]
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Norway
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State/province [84]
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Levanger
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Country [85]
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Norway
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Lillehammer
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Country [86]
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Norway
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State/province [86]
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Trondheim
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Country [87]
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Poland
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State/province [87]
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Bydgoszcz
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Country [88]
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Poland
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State/province [88]
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Katowice
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Country [89]
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Poland
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State/province [89]
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Lublin
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Country [90]
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Poland
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State/province [90]
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Wroclaw
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Country [91]
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Puerto Rico
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State/province [91]
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Caguas
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Country [92]
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Puerto Rico
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State/province [92]
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Ponce
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Country [93]
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Puerto Rico
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State/province [93]
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San Juan
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Country [94]
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Slovakia
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State/province [94]
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Piestany
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Country [95]
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South Africa
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State/province [95]
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Berea, Durban
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Country [96]
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South Africa
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State/province [96]
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Cape Town
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Country [97]
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South Africa
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State/province [97]
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Port Elizabeth
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Country [98]
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South Africa
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State/province [98]
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Pretoria
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Country [99]
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South Africa
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Soweto
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Country [100]
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Spain
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State/province [100]
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A Coruna
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Country [101]
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Spain
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State/province [101]
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Bilbao
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Country [102]
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Spain
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State/province [102]
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Elche (Alicante)
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Country [103]
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Spain
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State/province [103]
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Madrid
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Country [104]
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Spain
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State/province [104]
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Oviedo
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Country [105]
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Spain
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State/province [105]
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Santiago de Compostela
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Country [106]
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Spain
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State/province [106]
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Zaragoza
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Country [107]
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Sweden
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State/province [107]
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Eskilstuna
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Country [108]
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Sweden
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State/province [108]
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Falun
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Country [109]
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Sweden
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State/province [109]
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Malmoe
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Country [110]
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Sweden
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State/province [110]
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Stockholm
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Country [111]
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Sweden
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State/province [111]
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Uppsala
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Country [112]
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United Kingdom
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State/province [112]
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Bath
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Country [113]
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United Kingdom
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State/province [113]
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Huddersfield
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Country [114]
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United Kingdom
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State/province [114]
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Leeds
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Country [115]
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United Kingdom
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State/province [115]
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London
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Country [116]
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United Kingdom
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State/province [116]
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Newcastle upon Tyne
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Country [117]
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United Kingdom
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State/province [117]
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Oxford
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Country [118]
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United Kingdom
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State/province [118]
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Southampton
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Country [119]
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United Kingdom
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York
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott
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Address
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Ethics approval
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Summary
Brief summary
This study compared the safety and efficacy of combination therapy with adalimumab plus
methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early
rheumatoid arthritis (RA).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00420927
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Laura Redden, MD, PhD
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Address
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Abbott
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Phone
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00420927
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