Expired Study
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Hemet, California 92543


Purpose:

Study to Determine the Effects of Different Doses of Methotrexate (MTX) when taken with Adalimumab in Subjects with Early Rheumatoid Arthritis (RA).


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 2009 and has a disease duration of less than 1 year from diagnosis by a licensed health care provider - Subject must meet the following criteria: DAS28(CRP) ≥3.2 at the Baseline Visit only - At least 6 swollen joints out of 66 assessed (at the Screening and Baseline visits), at least 8 tender joints out of 68 assessed at the Screening and Baseline visits) - 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 (HB): HBs Ag (surface antigen) positive (+) or detected sensitivity on the HBV-DNA 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


Study is Available At:


Original ID:

M12-073


NCT ID:

NCT01185301


Secondary ID:

2010-019514-24


Study Acronym:

CONCERTO


Brief Title:

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


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)


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

AbbVie


Oversight Authority:

  • United States: Food and Drug Administration
  • Germany: Paul-Ehrlich-Institut
  • Czech Republic: State Institute for Drug Control
  • Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • Canada: Health Canada
  • Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
  • Austria: Federal Office for Safety in Health Care
  • Belgium: Federal Agency for Medicinal Products and Health Products
  • Spain: Ministry of Health


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

395


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dawn Carlson, MD
Study Director
AbbVie

Study Dates

Start Date:October 2010
Completion Date:September 2012
Completion Type:Actual
Primary Completion Date:September 2012
Primary Completion Type:Actual
Verification Date:February 2013
Last Changed Date:March 5, 2013
First Received Date:August 18, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Health Assessment Questionnaire Disability Index (HAQ-DI) Subject Proportion Change
Time Frame:Week 26
Safety Issues:False
Description:Proportion of subjects with Δ HAQ-DI ≥ -0.22 at Week 26
Outcome Type:Secondary Outcome
Measure:Health Assessment Questionnaire Disability Index (HAQ-DI) Score Change
Time Frame:Week 26
Safety Issues:False
Description:Change in HAQ-DI at Week 26
Outcome Type:Secondary Outcome
Measure:DAS28(CRP)
Time Frame:Week 26
Safety Issues:False
Description:AS28(CRP) < 2.6 at Week 26
Outcome Type:Secondary Outcome
Measure:Radiographic Progression
Time Frame:Week 26
Safety Issues:False
Description:Proportion of subjects with no radiographic progression (ΔmTSS ≤ 0.5) at Week 26
Outcome Type:Secondary Outcome
Measure:Change in modified Total Sharp Score (ΔmTSS)
Time Frame:Week 26
Safety Issues:False
Description:Change in modified Total Sharp Score (ΔmTSS) at Week 26
Outcome Type:Secondary Outcome
Measure:American College of Rheumatology (ACR) 20/50/70/90/100 criteria
Time Frame:Week 26
Safety Issues:False
Description:Response defined by ACR 20/50/70/90/100 criteria at Week 26
Outcome Type:Primary Outcome
Measure:28-Joint Disease Activity Score (DAS28) of C-reactive Proteins (CRP) (DAS28(CRP)) < 3.2
Time Frame:Week 26
Safety Issues:False
Description:Proportion of subjects achieving low disease activity as defined by a clinical response (DAS28(CRP) < 3.2) at Week 26

Study Interventions

Intervention Type:Biological
Name:adalimumab
Description:Pre-filled syringe every other week
Arm Name:2.5mg Arm
Other Name:Humira
Intervention Type:Drug
Name:methotrexate
Description:weekly oral capsule dosing
Arm Name:2.5mg Arm

Study Arms

Study Arm Type:Active Comparator
Arm Name:2.5mg Arm
Description:2.5mg Methotrexate (MTX) weekly with 40mg adalimumab biweekly for 26 weeks.
Study Arm Type:Active Comparator
Arm Name:5mg Arm
Description:5mg MTX weekly with 40mg adalimumab biweekly for 26 weeks.
Study Arm Type:Active Comparator
Arm Name:10mg Arm
Description:10mg MTX weekly with 40mg adalimumab biweekly for 26 weeks.
Study Arm Type:Active Comparator
Arm Name:20mg Arm
Description:40mg adalimumab biweekly for 26 weeks. Dose escalation from 10mg to 20mg in 2.5mg increments every other week (10mg x 2 weeks, 12.5mg x 2 weeks, 15mg x 2 weeks, 17.5 mg x 2 weeks). 20mg MTX for 18 weeks.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:AbbVie (prior sponsor, Abbott)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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