Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)
NCT ID: NCT01185301
Last Updated: 2013-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
395 participants
INTERVENTIONAL
2010-10-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ADA + 2.5 mg MTX
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
adalimumab
Pre-filled syringe every other week
methotrexate
weekly oral capsule dosing
ADA + 5 mg MTX
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
adalimumab
Pre-filled syringe every other week
methotrexate
weekly oral capsule dosing
ADA + 10 mg MTX
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
adalimumab
Pre-filled syringe every other week
methotrexate
weekly oral capsule dosing
ADA + 20 mg MTX
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
adalimumab
Pre-filled syringe every other week
methotrexate
weekly oral capsule dosing
Interventions
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adalimumab
Pre-filled syringe every other week
methotrexate
weekly oral capsule dosing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has a diagnosis of Rheumatoid Arthritis (RA) as defined by either the 1987-revised American College of Rheumatology (ACR) classification criteria or the new ACR/ European League Against Rheumatism (EULAR) diagnostic criteria for RA 2010 and has a disease duration of less than 1 year from diagnosis by a licensed health care provider
* Subject must meet the following criteria:
1. Disease Activity Score of C-reactive Protein (DAS28\[CRP\]) ≥ 3.2 (at the Baseline visit only)
2. At least 6 swollen joints out of 66 assessed (at the Screening and Baseline visits)
3. At least 8 tender joints out of 68 assessed (at the Screening and Baseline visits)
4. C-reactive protein (CRP) ≥ 1.5 mg/dL (at the Screening visit only), or erythrocyte sedimentation rate (ESR) ≥ 28 mm/1h (at the Screening and Baseline visits)
5. Fulfill at least one of the following three criteria: Rheumatoid Factor (RF) positive, have at least 1 bony erosion, anti-cyclic citrullinated peptide (anti-CCP) antibody positive
* Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and a 12-lead electrocardiogram (ECG) performed during Screening
Exclusion Criteria
* Subject has been previously treated with greater than 1 disease modifying antirheumatic drugs (DMARDs) or with methotrexate (MTX)
* Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study)
* Subject has chronic arthritis diagnosed before age 17 years
* History of invasive infection (e.g., listeriosis and histoplasmosis), chronic or active Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB)
* Hepatitis B virus: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the hepatitis B virus DNA (HBV DNA) polymerase chain reaction (PCR) qualitative test
* Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to the Baseline visit
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
18 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Dawn Carlson, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 38973
Huntsville, Alabama, United States
Site Reference ID/Investigator# 41962
Mesa, Arizona, United States
Site Reference ID/Investigator# 39260
Phoenix, Arizona, United States
Site Reference ID/Investigator# 45323
Little Rock, Arkansas, United States
Site Reference ID/Investigator# 38912
Hemet, California, United States
Site Reference ID/Investigator# 39673
Victorville, California, United States
Site Reference ID/Investigator# 38909
Jacksonville, Florida, United States
Site Reference ID/Investigator# 40422
Miami, Florida, United States
Site Reference ID/Investigator# 38910
Sarasota, Florida, United States
Site Reference ID/Investigator# 44284
Atlanta, Georgia, United States
Site Reference ID/Investigator# 38907
Gainesville, Georgia, United States
Site Reference ID/Investigator# 38972
Lawrenceville, Georgia, United States
Site Reference ID/Investigator# 39670
Rock Island, Illinois, United States
Site Reference ID/Investigator# 42282
Springfield, Illinois, United States
Site Reference ID/Investigator# 38911
Wichita, Kansas, United States
Site Reference ID/Investigator# 39672
Covington, Louisiana, United States
Site Reference ID/Investigator# 42204
Omaha, Nebraska, United States
Site Reference ID/Investigator# 40651
Clifton, New Jersey, United States
Site Reference ID/Investigator# 41422
Freehold, New Jersey, United States
Site Reference ID/Investigator# 41424
The Bronx, New York, United States
Site Reference ID/Investigator# 40463
Greenville, North Carolina, United States
Site Reference ID/Investigator# 42202
Columbus, Ohio, United States
Site Reference ID/Investigator# 44282
Norman, Oklahoma, United States
Site Reference ID/Investigator# 41423
Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 38971
Charleston, South Carolina, United States
Site Reference ID/Investigator# 39666
Jackson, Tennessee, United States
Site Reference ID/Investigator# 39643
Dallas, Texas, United States
Site Reference ID/Investigator# 45325
Dallas, Texas, United States
Site Reference ID/Investigator# 52042
Houston, Texas, United States
Site Reference ID/Investigator# 40602
Seattle, Washington, United States
Site Reference ID/Investigator# 44924
Buenos Aires, , Argentina
Site Reference ID/Investigator# 44926
Buenos Aires, , Argentina
Site Reference ID/Investigator# 44925
Rosario, Santa Fe, , Argentina
Site Reference ID/Investigator# 47302
San Juan, , Argentina
Site Reference ID/Investigator# 44928
Graz, , Austria
Site Reference ID/Investigator# 44930
Vienna, , Austria
Site Reference ID/Investigator# 44927
Vienna, , Austria
Site Reference ID/Investigator# 44934
Brussels, , Belgium
Site Reference ID/Investigator# 44935
Genk, , Belgium
Site Reference ID/Investigator# 44933
Gilly, , Belgium
Site Reference ID/Investigator# 44932
Liège, , Belgium
Site Reference ID/Investigator# 43783
Edmonton, , Canada
Site Reference ID/Investigator# 43782
Winnipeg, , Canada
Site Reference ID/Investigator# 44937
Brno, , Czechia
Site Reference ID/Investigator# 48962
České Budějovice, , Czechia
Site Reference ID/Investigator# 44939
Ostrava, , Czechia
Site Reference ID/Investigator# 44936
Prague, , Czechia
Site Reference ID/Investigator# 44938
Uherské Hradiště, , Czechia
Site Reference ID/Investigator# 48963
Zlín, , Czechia
Site Reference ID/Investigator# 44941
Berlin, , Germany
Site Reference ID/Investigator# 44945
Buch, , Germany
Site Reference ID/Investigator# 44942
Munich, , Germany
Site Reference ID/Investigator# 44944
Ratingen, , Germany
Site Reference ID/Investigator# 44943
Zerbst, , Germany
Site Reference ID/Investigator# 44946
Bydgoszcz, , Poland
Site Reference ID/Investigator# 44982
Lodz, , Poland
Site Reference ID/Investigator# 46584
Torun, , Poland
Site Reference ID/Investigator# 44984
Warsaw, , Poland
Site Reference ID/Investigator# 44983
Warsaw, , Poland
Site Reference ID/Investigator# 38975
Caguas, , Puerto Rico
Site Reference ID/Investigator# 40122
San Juan, , Puerto Rico
Site Reference ID/Investigator# 39693
San Juan, , Puerto Rico
Site Reference ID/Investigator# 38916
San Juan, , Puerto Rico
Site Reference ID/Investigator# 39692
Vega Baja, , Puerto Rico
Site Reference ID/Investigator# 44947
A Coruña, , Spain
Site Reference ID/Investigator# 44987
Elche (Alicante), , Spain
Site Reference ID/Investigator# 44948
Oviedo (Asturias), , Spain
Site Reference ID/Investigator# 47782
Valencia, , Spain
Countries
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References
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Goss SL, Klein CE, Jin Z, Locke CS, Rodila RC, Kupper H, Burmester GR, Awni WM. Methotrexate Dose in Patients With Early Rheumatoid Arthritis Impacts Methotrexate Polyglutamate Pharmacokinetics, Adalimumab Pharmacokinetics, and Efficacy: Pharmacokinetic and Exposure-response Analysis of the CONCERTO Trial. Clin Ther. 2018 Feb;40(2):309-319. doi: 10.1016/j.clinthera.2018.01.002.
Burmester GR, Kaeley GS, Kavanaugh AF, Gabay C, MacCarter DK, Nash P, Takeuchi T, Goss SL, Rodila R, Chen K, Kupper H, Kalabic J. Treatment efficacy and methotrexate-related toxicity in patients with rheumatoid arthritis receiving methotrexate in combination with adalimumab. RMD Open. 2017 Sep 17;3(2):e000465. doi: 10.1136/rmdopen-2017-000465. eCollection 2017.
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Related Links
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Related Info
Other Identifiers
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2010-019514-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M12-073
Identifier Type: -
Identifier Source: org_study_id