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Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis | Clinical Trials | Clareo Health

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Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Parallel-group, Multicenter Study to Demonstrate Similar Efficacy and to Compare Safety and Immunogenicity of GP2017 and Humira® in Patients With Moderate to Severe Active Rheumatoid Arthritis

NCT02744755•Sandoz

View on ClinicalTrials.gov

Summary

Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

Detailed Description

The purpose of this study is to demonstrate similar efficacy and safety of GP2017 and US-licensed Humira® in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to Disease modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must have been diagnosed with RA ≥ 6 months prior to screening
•2. Patients must have active disease, defined as DAS28-CRP ≥ 3.2 at the time of screening
•3. Patients must have CRP levels above 5mg/l or ESR levels above the upper limits of normal
•4. Patients must have had inadequate clinical response to MTX 10 - 25 mg/week

Exclusion Criteria

•1. Previous treatment with adalimumab, other anti-TNFα therapies or cell depleting agents, e.g. anti-CD20 therapy
•2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during treatment
•3. Nursing (lactating) or pregnant women
•4. History of or ongoing inflammatory or autoimmune diseases other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
•5. Systemic corticosteroids \> 7.5mg/day within 4 weeks prior to baseline
•6. History or presence of cancer or lymphoproliferative disease other than a successfully and completely treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix and/or removed non-invasive colon polyps, with no evidence of recurrence
•7. History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (New York Heart Association III-IV), active peptic ulcer disease, recent stroke (within 3 months)
•8. Subject known to have immune deficiency, history of positive human immunodeficiency virus (HIV) status or immunocompromised for other reasons
•9. History of clinically significant hematologic (e.g. severe anemia, leucopenia, thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis, cirrhosis, hepatitis)
•10. History of persistent chronic infection; recurrent infection or active infections
+3 more criteria

Locations (83)

Arizona Arthritis & Rheumatology

Mesa, Arizona, United States

Sun Valley Arthritis Center Ltd.

Peoria, Arizona, United States

Medvin Clinical Research

Covina, California, United States

MD Med Corp

Hemet, California, United States

Talbert Medical Group

Huntington Beach, California, United States

Denver Arthritis Clinic

Denver, Colorado, United States

Joao Nascimento (Private Practice)

Bridgeport, Connecticut, United States

Arthritis & Rheumatic Disease Specialties

Aventura, Florida, United States

RASF - Clinical Research Center

Boca Raton, Florida, United States

QPS MRA (Miami Research Associates)

Miami, Florida, United States

Key Dates

Start Date

March 31, 2016

Primary Completion Date

January 31, 2017

Completion Date

September 26, 2017

Last Updated

December 19, 2018

Enrollment

353

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

Adalimumab - GP2017

BIOLOGICAL

Adalimumab - US licensed Humira

BIOLOGICAL

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITING

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

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Plant-Based Diet for Patients With Rheumatoid Arthritis

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