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Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Early Rheumatoid Arthritis

Intervention: adalimumab (Biological); methotrexate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Dawn Carlson, MD, Study Director, Affiliation: AbbVie

Summary

The purpose of this study is to determine the effects of different doses of methotrexate (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).

Clinical Details

Official title: A Double-Blind, Randomized, Parallel-Arm, Multicenter Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy With Adalimumab in Subjects With Early Rheumatoid Arthritis (CONCERTO)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Participants With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) Low Disease Activity at Week 26

Secondary outcome:

Percentage of Participants With DAS28(CRP) Remission at Week 26

Percentage of Participants With American College of Rheumatology (ACR) 20 Criteria Response at Week 26

Percentage of Participants With American College of Rheumatology (ACR) 50 Criteria Response at Week 26

Percentage of Participants With American College of Rheumatology (ACR) 70 Criteria Response at Week 26

Percentage of Participants With American College of Rheumatology (ACR) 90 Criteria Response at Week 26

Percentage of Participants With American College of Rheumatology (ACR) 100 Criteria Response at Week 26

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 26

Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ -0.22 at Week 26

Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26

Percentage of Participants With No Radiographic Progression at Week 26

Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 26

Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 26

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female subjects at least 18 years of age

- 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 previous exposure to any systemic biologic therapy including adalimumab

- 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

Locations and Contacts

Site Reference ID/Investigator# 44924, Buenos Aires C1055AAF, Argentina

Site Reference ID/Investigator# 44926, Buenos Aires C1425DTG, Argentina

Site Reference ID/Investigator# 44925, Rosario, Santa Fe S2000PBJ, Argentina

Site Reference ID/Investigator# 47302, San Juan J5402DIL, Argentina

Site Reference ID/Investigator# 44928, Graz 80360, Austria

Site Reference ID/Investigator# 44927, Vienna 1100, Austria

Site Reference ID/Investigator# 44930, Vienna 1090, Austria

Site Reference ID/Investigator# 44934, Brussels 1200, Belgium

Site Reference ID/Investigator# 44935, Genk 3600, Belgium

Site Reference ID/Investigator# 44933, Gilly 6060, Belgium

Site Reference ID/Investigator# 44932, Liege 4000, Belgium

Site Reference ID/Investigator# 43783, Edmonton T5M 0H4, Canada

Site Reference ID/Investigator# 43782, Winnipeg R3A 1M3, Canada

Site Reference ID/Investigator# 44937, Brno 63800, Czech Republic

Site Reference ID/Investigator# 48962, Ceske Budejovice 37021, Czech Republic

Site Reference ID/Investigator# 44939, Ostrava 72200, Czech Republic

Site Reference ID/Investigator# 44936, Prague 2 128 50, Czech Republic

Site Reference ID/Investigator# 44938, Uherske Hradiste 686 01, Czech Republic

Site Reference ID/Investigator# 48963, Zlin 76001, Czech Republic

Site Reference ID/Investigator# 44945, Berlin-Buch 13125, Germany

Site Reference ID/Investigator# 44941, Berlin 10117, Germany

Site Reference ID/Investigator# 44942, Munich 80336, Germany

Site Reference ID/Investigator# 44944, Ratingen 40882, Germany

Site Reference ID/Investigator# 44943, Zerbst 39261, Germany

Site Reference ID/Investigator# 44946, Bydgoszcz 85168, Poland

Site Reference ID/Investigator# 44982, Lodz 90-242, Poland

Site Reference ID/Investigator# 46584, Torun 87-100, Poland

Site Reference ID/Investigator# 44983, Warsaw 02-256, Poland

Site Reference ID/Investigator# 44984, Warsaw 02-118, Poland

Site Reference ID/Investigator# 38975, Caguas 00725, Puerto Rico

Site Reference ID/Investigator# 38916, San Juan 00936-8344, Puerto Rico

Site Reference ID/Investigator# 39693, San Juan 00936-5067, Puerto Rico

Site Reference ID/Investigator# 40122, San Juan 00906-6312, Puerto Rico

Site Reference ID/Investigator# 39692, Vega Baja 00693, Puerto Rico

Site Reference ID/Investigator# 44947, A Coruna 15006, Spain

Site Reference ID/Investigator# 44987, Elche (Alicante) 03203, Spain

Site Reference ID/Investigator# 44948, Oviedo (Asturias) 33006, Spain

Site Reference ID/Investigator# 47782, Valencia 46026, Spain

Site Reference ID/Investigator# 38973, Huntsville, Alabama 35801, United States

Site Reference ID/Investigator# 41962, Mesa, Arizona 85202, United States

Site Reference ID/Investigator# 39260, Phoenix, Arizona 85031, United States

Site Reference ID/Investigator# 45323, Little Rock, Arkansas 72205, United States

Site Reference ID/Investigator# 38912, Hemet, California 92543, United States

Site Reference ID/Investigator# 39673, Victorville, California 92395, United States

Site Reference ID/Investigator# 38909, Jacksonville, Florida 32209, United States

Site Reference ID/Investigator# 40422, Miami, Florida 33169, United States

Site Reference ID/Investigator# 38910, Sarasota, Florida 34239, United States

Site Reference ID/Investigator# 44284, Atlanta, Georgia 30312, United States

Site Reference ID/Investigator# 38907, Gainesville, Georgia 30501, United States

Site Reference ID/Investigator# 38972, Lawrenceville, Georgia 30045, United States

Site Reference ID/Investigator# 39670, Rock Island, Illinois 61201, United States

Site Reference ID/Investigator# 42282, Springfield, Illinois 62704, United States

Site Reference ID/Investigator# 38911, Wichita, Kansas 67203, United States

Site Reference ID/Investigator# 39672, Covington, Louisiana 70433, United States

Site Reference ID/Investigator# 42204, Omaha, Nebraska 68114, United States

Site Reference ID/Investigator# 40651, Clifton, New Jersey 07012, United States

Site Reference ID/Investigator# 41422, Freehold, New Jersey 07728, United States

Site Reference ID/Investigator# 41424, Bronx, New York 10467, United States

Site Reference ID/Investigator# 40463, Greenville, North Carolina 27834, United States

Site Reference ID/Investigator# 42202, Columbus, Ohio 43213, United States

Site Reference ID/Investigator# 44282, Norman, Oklahoma 73069, United States

Site Reference ID/Investigator# 41423, Duncansville, Pennsylvania 16635, United States

Site Reference ID/Investigator# 38971, Charleston, South Carolina 29406, United States

Site Reference ID/Investigator# 39666, Jackson, Tennessee 38305, United States

Site Reference ID/Investigator# 39643, Dallas, Texas 75231, United States

Site Reference ID/Investigator# 45325, Dallas, Texas 75246, United States

Site Reference ID/Investigator# 52042, Houston, Texas 77074, United States

Site Reference ID/Investigator# 40602, Seattle, Washington 98101, United States

Additional Information

Starting date: October 2010
Last updated: September 11, 2013

Page last updated: August 23, 2015

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