Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis (OPTIMA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00420927
First received: January 9, 2007
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention Phase
Rheumatoid Arthritis
Biological: adalimumab
Drug: methotrexate
Biological: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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).

  • Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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).

  • Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in DAS28 Score at Week 78 [ Time Frame: Baseline to Week 78 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in CDAI Score at Week 78 [ Time Frame: Baseline to Week 78 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in SDAI Score at Week 78 [ Time Frame: Baseline to Week 78 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78 [ Time Frame: Baseline to Week 78 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Week 78 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1032
Study Start Date: December 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: adalimumab
Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
Other Names:
  • Humira
  • D2E7
Drug: 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.
Biological: placebo
Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
Experimental: ADA+MTX/ADA+MTX (Arm2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
Biological: adalimumab
Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
Other Names:
  • Humira
  • D2E7
Drug: 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.
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
Biological: adalimumab
Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
Other Names:
  • Humira
  • D2E7
Drug: 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.
Experimental: PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
Drug: 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.
Biological: placebo
Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
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.
Biological: adalimumab
Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
Other Names:
  • Humira
  • D2E7
Drug: 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.
Biological: placebo
Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)

Detailed Description:

This was a 78-week, multicenter, randomized, double-blind, double-treatment period study designed to compare the safety and efficacy of adalimumab and MTX with placebo and MTX in subjects with early RA. Subjects were randomized to receive adalimumab 40 mg every other week (eow) or placebo subcutaneous injections in combination with orally administered MTX for 26 weeks (Period 1). All subjects in all arms received open-label MTX weekly throughout the study (both Period 1 and Period 2).

At Weeks 22 and 26, subjects were assessed for achievement of low disease activity, defined as a DAS28 score below 3.2. DAS28 is a measure of RA disease activity calculated using the number of tender and swollen joints (out of a total of 28), C-reactive protein level (CRP, a blood marker of inflammation), and the patient's global assessment of disease activity (indicated by marking a 10 cm line between very good and very bad). Subjects who achieved low disease activity at Week 22 and 26 in the adalimumab arm at the end of Period 1 were randomized to receive MTX monotherapy (placebo and MTX) or combination therapy (adalimumab and MTX) in a 1:1 ratio for the duration of Period 2 (52 weeks, i.e., to Week 78 of the study). Subjects achieving low disease activity at Week 22 and 26 in the placebo arm (MTX monotherapy) at the end of Period 1 continued to receive MTX monotherapy (and placebo injections in a blinded fashion) for the duration of Period 2. Subjects failing to achieve low disease activity at Week 22 and 26 at the end of Period 1 received open-label combination therapy during Period 2 regardless of treatment assignment in Period 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420927

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Locations
United States, Alabama
Site Reference ID/Investigator# 4560
Birmingham, Alabama, United States, 35205
Site Reference ID/Investigator# 4547
Birmingham, Alabama, United States, 35294-7201
Site Reference ID/Investigator# 6222
Huntsville, Alabama, United States, 35801
Site Reference ID/Investigator# 4537
Mobile, Alabama, United States, 36608
Site Reference ID/Investigator# 6758
Tuscaloosa, Alabama, United States, 35406
United States, California
Site Reference ID/Investigator# 9323
Hemet, California, United States, 92543
Site Reference ID/Investigator# 4568
La Jolla, California, United States, 92037-0943
Site Reference ID/Investigator# 4535
Palm Desert, California, United States, 92260
Site Reference ID/Investigator# 4571
Santa Monica, California, United States, 90404
Site Reference ID/Investigator# 9271
Torrance, California, United States, 90505
Site Reference ID/Investigator# 10746
Victorville, California, United States, 92395
United States, Colorado
Site Reference ID/Investigator# 4559
Denver, Colorado, United States, 80230
United States, Florida
Site Reference ID/Investigator# 6229
Aventura, Florida, United States, 33180
Site Reference ID/Investigator# 10603
Lake Mary, Florida, United States, 32746
Site Reference ID/Investigator# 9325
Orange Park, Florida, United States, 32073
Site Reference ID/Investigator# 4550
Palm Harbor, Florida, United States, 34684
Site Reference ID/Investigator# 4570
Sarasota, Florida, United States, 34239
Site Reference ID/Investigator# 4601
Tampa, Florida, United States, 33614
Site Reference ID/Investigator# 4552
Vero Beach, Florida, United States, 32960
United States, Idaho
Site Reference ID/Investigator# 10745
Meridian, Idaho, United States, 83642
United States, Illinois
Site Reference ID/Investigator# 4548
Chicago, Illinois, United States, 60612
Site Reference ID/Investigator# 4557
Springfield, Illinois, United States, 62704
United States, Kansas
Site Reference ID/Investigator# 4605
Wichita, Kansas, United States, 67203
United States, Maryland
Site Reference ID/Investigator# 10741
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Site Reference ID/Investigator# 6417
Fall River, Massachusetts, United States, 02720
United States, New Hampshire
Site Reference ID/Investigator# 4561
Dover, New Hampshire, United States, 03820
United States, New Jersey
Site Reference ID/Investigator# 11222
Freehold, New Jersey, United States, 07728
Site Reference ID/Investigator# 6228
Passaic, New Jersey, United States, 07055
United States, New Mexico
Site Reference ID/Investigator# 4544
Albuquerque, New Mexico, United States, 87102
United States, New York
Site Reference ID/Investigator# 12821
Bronx, New York, United States, 10461
Site Reference ID/Investigator# 4534
Orchard Park, New York, United States, 14127
Site Reference ID/Investigator# 9324
Plainview, New York, United States, 11803
Site Reference ID/Investigator# 4600
Smithtown, New York, United States, 11787
United States, Ohio
Site Reference ID/Investigator# 4549
Mayfield Village, Ohio, United States, 44143
United States, Oregon
Site Reference ID/Investigator# 6227
Bend, Oregon, United States, 97701
United States, Pennsylvania
Site Reference ID/Investigator# 4546
Duncansville, Pennsylvania, United States, 16635
Site Reference ID/Investigator# 4564
West Reading, Pennsylvania, United States, 19611-1124
Site Reference ID/Investigator# 4558
Wexford, Pennsylvania, United States, 15090
United States, South Carolina
Site Reference ID/Investigator# 4533
Charleston, South Carolina, United States, 29406
Site Reference ID/Investigator# 7482
Greenville, South Carolina, United States, 29601
United States, Tennessee
Site Reference ID/Investigator# 10743
Jackson, Tennessee, United States, 38305
Site Reference ID/Investigator# 4562
Nashville, Tennessee, United States, 37205
United States, Texas
Site Reference ID/Investigator# 4536
Dallas, Texas, United States, 75231
Site Reference ID/Investigator# 4538
Houston, Texas, United States, 77074
Site Reference ID/Investigator# 6899
San Antonio, Texas, United States, 78217
Site Reference ID/Investigator# 6381
Tyler, Texas, United States, 75701
United States, Washington
Site Reference ID/Investigator# 10744
Seattle, Washington, United States, 98133
United States, Wisconsin
Site Reference ID/Investigator# 4545
Glendale, Wisconsin, United States, 53217
Site Reference ID/Investigator# 4572
Oak Creek, Wisconsin, United States, 53154
Argentina
Site Reference ID/Investigator# 6346
Buenos Aires, Argentina, C1055AAF
Site Reference ID/Investigator# 3888
Buenos Aires, Argentina, C1015ABO
Site Reference ID/Investigator# 3886
Buenos Aires, Argentina, 1426AAL
Site Reference ID/Investigator# 3887
Quilmes, Argentina
Site Reference ID/Investigator# 3889
San Miguel de Tucuman, Argentina, T4000AXL
Australia
Site Reference ID/Investigator# 8380
Campsie, Sydney, Australia, 2194
Site Reference ID/Investigator# 6954
Clayton, Australia, 3168
Site Reference ID/Investigator# 6940
Malvern East, Australia, 3145
Austria
Site Reference ID/Investigator# 3915
Graz, Austria, 8036
Site Reference ID/Investigator# 3911
Graz, Austria, A-8020
Site Reference ID/Investigator# 3885
Vienna, Austria, 1100
Site Reference ID/Investigator# 3916
Vienna, Austria, 1130
Site Reference ID/Investigator# 3880
Vienna, Austria, 1090
Site Reference ID/Investigator# 7792
Vienna, Austria, 1160
Belgium
Site Reference ID/Investigator# 3914
Brussels, Belgium, 1200
Site Reference ID/Investigator# 3909
Genk, Belgium, 3600
Site Reference ID/Investigator# 3881
Gilly, Belgium, 6060
Site Reference ID/Investigator# 3376
Liege, Belgium, 4000
Site Reference ID/Investigator# 6720
Mechelen, Belgium, 2800
Site Reference ID/Investigator# 6718
Sint-Niklaas, Belgium, 9100
Site Reference ID/Investigator# 3910
Yvoir, Belgium, 5530
Canada
Site Reference ID/Investigator# 6701
Burlington, Canada, L7R 1E2
Site Reference ID/Investigator# 6834
Edmonton, Canada, T5M 0H4
Site Reference ID/Investigator# 7197
Halifax, Canada, B3H 4K4
Site Reference ID/Investigator# 3884
Hamilton, Canada, L8N 2B6
Site Reference ID/Investigator# 3883
Hamilton, Canada, L8N 1Y2
Site Reference ID/Investigator# 3903
Montreal, Canada, H3Z 2Z3
Site Reference ID/Investigator# 3907
Montreal, Canada, H2L 1S6
Site Reference ID/Investigator# 5178
Ottawa, Canada, K2G 6E2
Site Reference ID/Investigator# 3904
Richmond, Canada, V7C 5L9
Site Reference ID/Investigator# 3912
Sainte-Foy, Quebec, Canada, G1W 4R4
Site Reference ID/Investigator# 3901
Sarnia, Canada, N7T 5W6
Site Reference ID/Investigator# 3906
St. John's, Canada, A1A 5E8
Site Reference ID/Investigator# 6542
Toronto, Canada, M9B 1B1
Site Reference ID/Investigator# 3882
Victoria, Canada, V8V 3P9
Site Reference ID/Investigator# 5616
Windsor, Canada, N8X 5A6
Site Reference ID/Investigator# 3905
Winnipeg, Canada, R3A 1M4
Site Reference ID/Investigator# 5847
Winnipeg, Canada, R3A 1M3
Czech Republic
Site Reference ID/Investigator# 3968
Brno, Czech Republic, 65691
Site Reference ID/Investigator# 3971
Hradec Kralove, Czech Republic, 500 05
Site Reference ID/Investigator# 5559
Ostrava, Czech Republic, 72200
Site Reference ID/Investigator# 3969
Prague 2, Czech Republic, 128 50
Site Reference ID/Investigator# 5548
Uherske Hradiste, Czech Republic, 686 01
France
Site Reference ID/Investigator# 3982
Amiens, France, 80054
Site Reference ID/Investigator# 3979
Le Mans, France, 72037
Site Reference ID/Investigator# 3983
Paris Cedex 14, France, 75679
Site Reference ID/Investigator# 3918
Strasbourg, France, 67098
Germany
Site Reference ID/Investigator# 3926
Bad Nauheim, Germany, D-61231
Site Reference ID/Investigator# 3928
Berlin-Buch, Germany, 13125
Site Reference ID/Investigator# 3978
Damp, Germany, 24351
Site Reference ID/Investigator# 3924
Duesseldorf, Germany, 40225
Site Reference ID/Investigator# 3965
Frankfurt, Germany, 60590
Site Reference ID/Investigator# 3927
Frankfurt/Main, Germany, 60596
Site Reference ID/Investigator# 3925
Freiburg, Germany, 79106
Site Reference ID/Investigator# 4291
Halle, Germany, 06120
Site Reference ID/Investigator# 8489
Hofheim, Germany, D-65719
Site Reference ID/Investigator# 3923
Munich, Germany, 80336
Site Reference ID/Investigator# 8483
Osnabrueck, Germany, D-49074
Site Reference ID/Investigator# 8486
Ratingen, Germany, 40882
Site Reference ID/Investigator# 3919
Vogelsang-Gommern, Germany, 39245
Site Reference ID/Investigator# 6637
Zerbst, Germany, 39261
Hungary
Site Reference ID/Investigator# 3922
Budapest, Hungary, 1277
Site Reference ID/Investigator# 3921
Budapest, Hungary, 1023
Site Reference ID/Investigator# 3920
Debrecen, Hungary, 4012
Mexico
Site Reference ID/Investigator# 3824
Aguascallentes, Mexico, 20230
Site Reference ID/Investigator# 3822
Leon, Guanajuato, Mexico, 37000
Site Reference ID/Investigator# 3823
Mexico City, Mexico, CP 1300
Site Reference ID/Investigator# 3890
Mexico City, Mexico, 14389
Site Reference ID/Investigator# 3951
Mexico City, Mexico, 10700
Site Reference ID/Investigator# 3891
Mexico City, Mexico, CP 14050
Site Reference ID/Investigator# 3825
Mexico City, Mexico, 10700
Netherlands
Site Reference ID/Investigator# 3947
Arnem, Netherlands, 6815 AD
Site Reference ID/Investigator# 3948
Hilversum, Netherlands, 1213XZ
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, New Zealand
Norway
Site Reference ID/Investigator# 7607
Alesund, Norway, N-6026
Site Reference ID/Investigator# 7935
Kristiansand S, Norway, 4615
Site Reference ID/Investigator# 7506
Levanger, Norway, 7600
Site Reference ID/Investigator# 7511
Lillehammer, Norway, N-2609
Site Reference ID/Investigator# 7500
Trondheim, Norway, N-7006
Poland
Site Reference ID/Investigator# 3963
Bydgoszcz, Poland, 85168
Site Reference ID/Investigator# 3962
Katowice, Poland, 40635
Site Reference ID/Investigator# 5560
Lublin, Poland, 20954
Site Reference ID/Investigator# 3961
Wroclaw, Poland, 53-342
Puerto Rico
Site Reference ID/Investigator# 3944
Caguas, Puerto Rico, 00725
Site Reference ID/Investigator# 3937
Ponce, Puerto Rico, 00716
Site Reference ID/Investigator# 3935
San Juan, Puerto Rico, 00936-5067
Site Reference ID/Investigator# 3934
San Juan, Puerto Rico, 00918
Slovakia
Site Reference ID/Investigator# 3960
Piestany, Slovakia, 92112
Site Reference ID/Investigator# 3959
Piestany, Slovakia, 92112
South Africa
Site Reference ID/Investigator# 7177
Berea, Durban, South Africa, 4001
Site Reference ID/Investigator# 7175
Cape Town, South Africa, 7405
Site Reference ID/Investigator# 7178
Cape Town, South Africa, 7500
Site Reference ID/Investigator# 7176
Port Elizabeth, South Africa, 6045
Site Reference ID/Investigator# 7172
Pretoria, South Africa, 0028
Site Reference ID/Investigator# 7174
Soweto, South Africa, 2013
Spain
Site Reference ID/Investigator# 3955
A Coruna, Spain, 15006
Site Reference ID/Investigator# 13661
Bilbao, Spain, 48013
Site Reference ID/Investigator# 3930
Elche (Alicante), Spain, 03203
Site Reference ID/Investigator# 3943
Madrid, Spain, 28034
Site Reference ID/Investigator# 3956
Madrid, Spain, 28007
Site Reference ID/Investigator# 8524
Madrid, Spain, 28006
Site Reference ID/Investigator# 3931
Madrid, Spain, 28046
Site Reference ID/Investigator# 3957
Oviedo, Spain, 33006
Site Reference ID/Investigator# 3954
Santiago de Compostela, Spain, 15706
Site Reference ID/Investigator# 3932
Zaragoza, Spain, 50009
Sweden
Site Reference ID/Investigator# 4015
Eskilstuna, Sweden, SE-631 88
Site Reference ID/Investigator# 3984
Falun, Sweden, SE-79182
Site Reference ID/Investigator# 4016
Malmoe, Sweden, 20502
Site Reference ID/Investigator# 4014
Stockholm, Sweden, 171 76
Site Reference ID/Investigator# 4017
Uppsala, Sweden, 75185
United Kingdom
Site Reference ID/Investigator# 4012
Bath, United Kingdom, BA1 1RL
Site Reference ID/Investigator# 8495
Huddersfield, United Kingdom, HD3 3EA
Site Reference ID/Investigator# 4048
Leeds, United Kingdom, LS7 4SA
Site Reference ID/Investigator# 4013
London, United Kingdom, SE1 9RT
Site Reference ID/Investigator# 4046
Newcastle upon Tyne, United Kingdom, NE7 7DN
Site Reference ID/Investigator# 4047
Oxford, United Kingdom, OX3 7LD
Site Reference ID/Investigator# 3985
Southampton, United Kingdom, S016 6YD
Site Reference ID/Investigator# 7977
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Abbott
Investigators
Study Director: Laura Redden, MD, PhD Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00420927     History of Changes
Other Study ID Numbers: M06-810, 2006-004139-31
Study First Received: January 9, 2007
Results First Received: July 1, 2011
Last Updated: April 16, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria : Federal Ministry for Labour, Health, and Social Affairs
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Ministry of Health, Welfare and Sport
New Zealand: Health Research Council
New Zealand: Ministry of Health
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Institutional Review Board

Keywords provided by Abbott:
Early Rheumatoid Arthritis
Tumor Necrosis Factor Optimization

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 18, 2014