Rheumatoid Arthritis Clinical Trial
— OPTIMAOfficial 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)
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).
Status | Completed |
Enrollment | 1032 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Site Reference ID/Investigator# 3886 | Buenos Aires | |
Argentina | Site Reference ID/Investigator# 3888 | Buenos Aires | |
Argentina | Site Reference ID/Investigator# 6346 | Buenos Aires | |
Argentina | Site Reference ID/Investigator# 3887 | Quilmes | |
Argentina | Site Reference ID/Investigator# 3889 | San Miguel de Tucuman | |
Australia | Site Reference ID/Investigator# 8380 | Campsie, Sydney | |
Australia | Site Reference ID/Investigator# 6954 | Clayton | |
Australia | Site Reference ID/Investigator# 6940 | Malvern East | |
Austria | Site Reference ID/Investigator# 3911 | Graz | |
Austria | Site Reference ID/Investigator# 3915 | Graz | |
Austria | Site Reference ID/Investigator# 3880 | Vienna | |
Austria | Site Reference ID/Investigator# 3885 | Vienna | |
Austria | Site Reference ID/Investigator# 3916 | Vienna | |
Austria | Site Reference ID/Investigator# 7792 | Vienna | |
Belgium | Site Reference ID/Investigator# 3914 | Brussels | |
Belgium | Site Reference ID/Investigator# 3909 | Genk | |
Belgium | Site Reference ID/Investigator# 3881 | Gilly | |
Belgium | Site Reference ID/Investigator# 3376 | Liege | |
Belgium | Site Reference ID/Investigator# 6720 | Mechelen | |
Belgium | Site Reference ID/Investigator# 6718 | Sint-Niklaas | |
Belgium | Site Reference ID/Investigator# 3910 | Yvoir | |
Canada | Site Reference ID/Investigator# 6701 | Burlington | |
Canada | Site Reference ID/Investigator# 6834 | Edmonton | |
Canada | Site Reference ID/Investigator# 7197 | Halifax | |
Canada | Site Reference ID/Investigator# 3883 | Hamilton | |
Canada | Site Reference ID/Investigator# 3884 | Hamilton | |
Canada | Site Reference ID/Investigator# 3903 | Montreal | |
Canada | Site Reference ID/Investigator# 3907 | Montreal | |
Canada | Site Reference ID/Investigator# 5178 | Ottawa | |
Canada | Site Reference ID/Investigator# 3904 | Richmond | |
Canada | Site Reference ID/Investigator# 3912 | Sainte-Foy, Quebec | |
Canada | Site Reference ID/Investigator# 3901 | Sarnia | |
Canada | Site Reference ID/Investigator# 3906 | St. John's | |
Canada | Site Reference ID/Investigator# 6542 | Toronto | |
Canada | Site Reference ID/Investigator# 3882 | Victoria | |
Canada | Site Reference ID/Investigator# 5616 | Windsor | |
Canada | Site Reference ID/Investigator# 3905 | Winnipeg | |
Canada | Site Reference ID/Investigator# 5847 | Winnipeg | |
Czech Republic | Site Reference ID/Investigator# 3968 | Brno | |
Czech Republic | Site Reference ID/Investigator# 3971 | Hradec Kralove | |
Czech Republic | Site Reference ID/Investigator# 5559 | Ostrava | |
Czech Republic | Site Reference ID/Investigator# 3969 | Prague 2 | |
Czech Republic | Site Reference ID/Investigator# 5548 | Uherske Hradiste | |
France | Site Reference ID/Investigator# 3982 | Amiens | |
France | Site Reference ID/Investigator# 3979 | Le Mans | |
France | Site Reference ID/Investigator# 3983 | Paris Cedex 14 | |
France | Site Reference ID/Investigator# 3918 | Strasbourg | |
Germany | Site Reference ID/Investigator# 3926 | Bad Nauheim | |
Germany | Site Reference ID/Investigator# 3928 | Berlin-Buch | |
Germany | Site Reference ID/Investigator# 3978 | Damp | |
Germany | Site Reference ID/Investigator# 3924 | Duesseldorf | |
Germany | Site Reference ID/Investigator# 3965 | Frankfurt | |
Germany | Site Reference ID/Investigator# 3927 | Frankfurt/Main | |
Germany | Site Reference ID/Investigator# 3925 | Freiburg | |
Germany | Site Reference ID/Investigator# 4291 | Halle | |
Germany | Site Reference ID/Investigator# 8489 | Hofheim | |
Germany | Site Reference ID/Investigator# 3923 | Munich | |
Germany | Site Reference ID/Investigator# 8483 | Osnabrueck | |
Germany | Site Reference ID/Investigator# 8486 | Ratingen | |
Germany | Site Reference ID/Investigator# 3919 | Vogelsang-Gommern | |
Germany | Site Reference ID/Investigator# 6637 | Zerbst | |
Hungary | Site Reference ID/Investigator# 3921 | Budapest | |
Hungary | Site Reference ID/Investigator# 3922 | Budapest | |
Hungary | Site Reference ID/Investigator# 3920 | Debrecen | |
Mexico | Site Reference ID/Investigator# 3824 | Aguascallentes | |
Mexico | Site Reference ID/Investigator# 3822 | Leon, Guanajuato | |
Mexico | Site Reference ID/Investigator# 3823 | Mexico City | |
Mexico | Site Reference ID/Investigator# 3825 | Mexico City | |
Mexico | Site Reference ID/Investigator# 3890 | Mexico City | |
Mexico | Site Reference ID/Investigator# 3891 | Mexico City | |
Mexico | Site Reference ID/Investigator# 3951 | Mexico City | |
Netherlands | Site Reference ID/Investigator# 3947 | Arnem | |
Netherlands | Site Reference ID/Investigator# 3948 | Hilversum | |
New Zealand | Site Reference ID/Investigator# 8485 | Auckland 6 | |
New Zealand | Site Reference ID/Investigator# 8488 | Hamilton | |
New Zealand | Site Reference ID/Investigator# 8496 | Timaru | |
New Zealand | Site Reference ID/Investigator# 8511 | Wellington | |
Norway | Site Reference ID/Investigator# 7607 | Alesund | |
Norway | Site Reference ID/Investigator# 7935 | Kristiansand S | |
Norway | Site Reference ID/Investigator# 7506 | Levanger | |
Norway | Site Reference ID/Investigator# 7511 | Lillehammer | |
Norway | Site Reference ID/Investigator# 7500 | Trondheim | |
Poland | Site Reference ID/Investigator# 3963 | Bydgoszcz | |
Poland | Site Reference ID/Investigator# 3962 | Katowice | |
Poland | Site Reference ID/Investigator# 5560 | Lublin | |
Poland | Site Reference ID/Investigator# 3961 | Wroclaw | |
Puerto Rico | Site Reference ID/Investigator# 3944 | Caguas | |
Puerto Rico | Site Reference ID/Investigator# 3937 | Ponce | |
Puerto Rico | Site Reference ID/Investigator# 3934 | San Juan | |
Puerto Rico | Site Reference ID/Investigator# 3935 | San Juan | |
Slovakia | Site Reference ID/Investigator# 3959 | Piestany | |
Slovakia | Site Reference ID/Investigator# 3960 | Piestany | |
South Africa | Site Reference ID/Investigator# 7177 | Berea, Durban | |
South Africa | Site Reference ID/Investigator# 7175 | Cape Town | |
South Africa | Site Reference ID/Investigator# 7178 | Cape Town | |
South Africa | Site Reference ID/Investigator# 7176 | Port Elizabeth | |
South Africa | Site Reference ID/Investigator# 7172 | Pretoria | |
South Africa | Site Reference ID/Investigator# 7174 | Soweto | |
Spain | Site Reference ID/Investigator# 3955 | A Coruna | |
Spain | Site Reference ID/Investigator# 13661 | Bilbao | |
Spain | Site Reference ID/Investigator# 3930 | Elche (Alicante) | |
Spain | Site Reference ID/Investigator# 3931 | Madrid | |
Spain | Site Reference ID/Investigator# 3943 | Madrid | |
Spain | Site Reference ID/Investigator# 3956 | Madrid | |
Spain | Site Reference ID/Investigator# 8524 | Madrid | |
Spain | Site Reference ID/Investigator# 3957 | Oviedo | |
Spain | Site Reference ID/Investigator# 3954 | Santiago de Compostela | |
Spain | Site Reference ID/Investigator# 3932 | Zaragoza | |
Sweden | Site Reference ID/Investigator# 4015 | Eskilstuna | |
Sweden | Site Reference ID/Investigator# 3984 | Falun | |
Sweden | Site Reference ID/Investigator# 4016 | Malmoe | |
Sweden | Site Reference ID/Investigator# 4014 | Stockholm | |
Sweden | Site Reference ID/Investigator# 4017 | Uppsala | |
United Kingdom | Site Reference ID/Investigator# 4012 | Bath | |
United Kingdom | Site Reference ID/Investigator# 8495 | Huddersfield | |
United Kingdom | Site Reference ID/Investigator# 4048 | Leeds | |
United Kingdom | Site Reference ID/Investigator# 4013 | London | |
United Kingdom | Site Reference ID/Investigator# 4046 | Newcastle upon Tyne | |
United Kingdom | Site Reference ID/Investigator# 4047 | Oxford | |
United Kingdom | Site Reference ID/Investigator# 3985 | Southampton | |
United Kingdom | Site Reference ID/Investigator# 7977 | York | |
United States | Site Reference ID/Investigator# 4544 | Albuquerque | New Mexico |
United States | Site Reference ID/Investigator# 6229 | Aventura | Florida |
United States | Site Reference ID/Investigator# 6227 | Bend | Oregon |
United States | Site Reference ID/Investigator# 4547 | Birmingham | Alabama |
United States | Site Reference ID/Investigator# 4560 | Birmingham | Alabama |
United States | Site Reference ID/Investigator# 12821 | Bronx | New York |
United States | Site Reference ID/Investigator# 4533 | Charleston | South Carolina |
United States | Site Reference ID/Investigator# 4548 | Chicago | Illinois |
United States | Site Reference ID/Investigator# 4536 | Dallas | Texas |
United States | Site Reference ID/Investigator# 4559 | Denver | Colorado |
United States | Site Reference ID/Investigator# 4561 | Dover | New Hampshire |
United States | Site Reference ID/Investigator# 4546 | Duncansville | Pennsylvania |
United States | Site Reference ID/Investigator# 6417 | Fall River | Massachusetts |
United States | Site Reference ID/Investigator# 11222 | Freehold | New Jersey |
United States | Site Reference ID/Investigator# 4545 | Glendale | Wisconsin |
United States | Site Reference ID/Investigator# 7482 | Greenville | South Carolina |
United States | Site Reference ID/Investigator# 9323 | Hemet | California |
United States | Site Reference ID/Investigator# 4538 | Houston | Texas |
United States | Site Reference ID/Investigator# 6222 | Huntsville | Alabama |
United States | Site Reference ID/Investigator# 10743 | Jackson | Tennessee |
United States | Site Reference ID/Investigator# 4568 | La Jolla | California |
United States | Site Reference ID/Investigator# 10603 | Lake Mary | Florida |
United States | Site Reference ID/Investigator# 4549 | Mayfield Village | Ohio |
United States | Site Reference ID/Investigator# 10745 | Meridian | Idaho |
United States | Site Reference ID/Investigator# 4537 | Mobile | Alabama |
United States | Site Reference ID/Investigator# 4562 | Nashville | Tennessee |
United States | Site Reference ID/Investigator# 4572 | Oak Creek | Wisconsin |
United States | Site Reference ID/Investigator# 9325 | Orange Park | Florida |
United States | Site Reference ID/Investigator# 4534 | Orchard Park | New York |
United States | Site Reference ID/Investigator# 4535 | Palm Desert | California |
United States | Site Reference ID/Investigator# 4550 | Palm Harbor | Florida |
United States | Site Reference ID/Investigator# 6228 | Passaic | New Jersey |
United States | Site Reference ID/Investigator# 9324 | Plainview | New York |
United States | Site Reference ID/Investigator# 6899 | San Antonio | Texas |
United States | Site Reference ID/Investigator# 4571 | Santa Monica | California |
United States | Site Reference ID/Investigator# 4570 | Sarasota | Florida |
United States | Site Reference ID/Investigator# 10744 | Seattle | Washington |
United States | Site Reference ID/Investigator# 4600 | Smithtown | New York |
United States | Site Reference ID/Investigator# 4557 | Springfield | Illinois |
United States | Site Reference ID/Investigator# 4601 | Tampa | Florida |
United States | Site Reference ID/Investigator# 9271 | Torrance | California |
United States | Site Reference ID/Investigator# 6758 | Tuscaloosa | Alabama |
United States | Site Reference ID/Investigator# 6381 | Tyler | Texas |
United States | Site Reference ID/Investigator# 4552 | Vero Beach | Florida |
United States | Site Reference ID/Investigator# 10746 | Victorville | California |
United States | Site Reference ID/Investigator# 4564 | West Reading | Pennsylvania |
United States | Site Reference ID/Investigator# 4558 | Wexford | Pennsylvania |
United States | Site Reference ID/Investigator# 10741 | Wheaton | Maryland |
United States | Site Reference ID/Investigator# 4605 | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Abbott |
United States, Argentina, Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Hungary, Mexico, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Slovakia, South Africa, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Week 78 | No |
Secondary | 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 | 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. | Week 78 | No |
Secondary | Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78 | 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. | Week 78 | No |
Secondary | Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78 | 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. | Week 78 | No |
Secondary | Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78 | 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. | Week 78 | No |
Secondary | Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78 | 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). | Week 78 | No |
Secondary | Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78 | 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). | Week 78 | No |
Secondary | Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78 | 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). | Week 78 | No |
Secondary | Change From Baseline in DAS28 Score at Week 78 | 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. | Baseline to Week 78 | No |
Secondary | Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78 | 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. | Week 78 | No |
Secondary | Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78 | 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. | Week 78 | No |
Secondary | Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78 | 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. | Week 78 | No |
Secondary | Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78 | 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. | Week 78 | No |
Secondary | Change From Baseline in CDAI Score at Week 78 | 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. | Baseline to Week 78 | No |
Secondary | Change From Baseline in SDAI Score at Week 78 | 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. | Baseline to Week 78 | No |
Secondary | Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78 | 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. | Baseline to Week 78 | No |
Secondary | 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 | 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. | Week 78 | No |
Secondary | 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 | 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. | Week 78 | No |
Secondary | 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 | 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. | Week 78 | No |
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