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Biological Response Modifier

DMARDs for Rheumatoid Arthritis

Phase 3
Recruiting
Led By James R O'Dell, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>19 yrs old at time of diagnosis of RA
Current active disease with at least 1 swollen joint
Must not have
Men and women of child bearing potential not willing to practice successful method of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether a certain type of arthritis medication can help predict clinical responses to other types of arthritis medication. All patients will receive a starting dose of the medication being tested, which may be adjusted by the investigator as needed. If a subject becomes intolerant to the medication being tested, the subject will be withdrawn from the study. Data from the study will be collected at the end of the trial.

Who is the study for?
This trial is for adults diagnosed with Rheumatoid Arthritis (RA) who meet specific criteria like morning stiffness, joint swelling, and positive RA factors. They must be starting a new DMARD medication and have stable doses of any other DMARDs or low-dose glucocorticoids. Pregnant individuals or those not using contraception are excluded.
What is being tested?
The study tests how well different Disease-Modifying Antirheumatic Drugs (DMARDs) work for treating RA over 16 weeks. It aims to find predictors of treatment response by adjusting dosages as needed and monitoring the generation of inflammation-related radicals in the blood.
What are the potential side effects?
Potential side effects from DMARDs can include nausea, liver issues, bone marrow suppression, increased infection risk, allergic reactions, lung problems, skin rashes, and gastrointestinal disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with rheumatoid arthritis after turning 19.
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I currently have at least one swollen joint.
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I have been diagnosed with RA and meet at least 4 of the ACR criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not willing to use contraception.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of disease-modifying antirheumatic drugs (DMARD) therapy for Rheumatoid Arthritis using American College of Rheumatology 50 (ACR50)
Predictors of disease-modifying antirheumatic drugs (DMARD) response in participants with rheumatoid arthritis (RA)
Secondary study objectives
Certain genetic factors as predictors of disease-modifying antirheumatic drugs (DMARD) response
Co-morbid conditions as predictors of disease-modifying antirheumatic drugs (DMARD) response
Serological factors as predictors of disease-modifying antirheumatic drugs (DMARD) response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

16Treatment groups
Active Control
Group I: Methotrexate TherapyActive Control1 Intervention
Subjects will receive methotrexate therapy for RA treatment.
Group II: Abatacept TherapyActive Control1 Intervention
Subjects will receive abatacept therapy for RA treatment.
Group III: Adalimumab TherapyActive Control1 Intervention
Subjects will receive adalimumab therapy for RA treatment.
Group IV: Azathioprine TherapyActive Control1 Intervention
Subjects will receive azathioprine therapy for RA treatment.
Group V: Barcitinib TherapyActive Control1 Intervention
Subjects will receive barcitinib therapy for RA treatment.
Group VI: Certolizumab TherapyActive Control1 Intervention
Subjects will receive certolizumab therapy for RA treatment.
Group VII: Etanercept TherapyActive Control1 Intervention
Subjects will receive etanercept therapy for RA treatment.
Group VIII: Golimumab TherapyActive Control1 Intervention
Subjects will receive golimumab therapy for RA treatment.
Group IX: Hydroxycholoroquine TherapyActive Control1 Intervention
Subjects will receive hydroxychloroquine therapy for RA treatment.
Group X: Infliximab TherapyActive Control1 Intervention
Subjects will receive infliximab therapy for RA treatment.
Group XI: Leflunomide TherapyActive Control1 Intervention
Subjects will receive leflunomide therapy for RA treatment.
Group XII: Minocycline TherapyActive Control1 Intervention
Subjects will receive minocycline therapy for RA treatment.
Group XIII: Rituximab TherapyActive Control1 Intervention
Subjects will receive rituximab therapy for RA treatment.
Group XIV: Sarilumab TherapyActive Control1 Intervention
Subjects will receive sarilumab therapy for RA treatment.
Group XV: Sulfasalazine TherapyActive Control1 Intervention
Subjects will receive sulfasalazine therapy for RA treatment.
Group XVI: Tofacitinib TherapyActive Control1 Intervention
Subjects will receive tofacitinib therapy for RA treatment.

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,144,986 Total Patients Enrolled
9 Trials studying Rheumatoid Arthritis
4,677 Patients Enrolled for Rheumatoid Arthritis
James R O'Dell, MDPrincipal InvestigatorUniversity of Nebraska
3 Previous Clinical Trials
1,110 Total Patients Enrolled
2 Trials studying Rheumatoid Arthritis
160 Patients Enrolled for Rheumatoid Arthritis

Media Library

Abatacept (Biological Response Modifier) Clinical Trial Eligibility Overview. Trial Name: NCT03414502 — Phase 3
Rheumatoid Arthritis Research Study Groups: Methotrexate Therapy, Abatacept Therapy, Adalimumab Therapy, Azathioprine Therapy, Barcitinib Therapy, Certolizumab Therapy, Etanercept Therapy, Golimumab Therapy, Hydroxycholoroquine Therapy, Infliximab Therapy, Leflunomide Therapy, Minocycline Therapy, Rituximab Therapy, Sarilumab Therapy, Sulfasalazine Therapy, Tofacitinib Therapy
Rheumatoid Arthritis Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT03414502 — Phase 3
Abatacept (Biological Response Modifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03414502 — Phase 3
~45 spots leftby Mar 2027
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