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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

Study 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 If a subject becomes intolerant to the medication being tested, the subject will be withdrawn from the study.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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the efficacy of DMARD therapy for Rheumatoid Arthritis as defined by attaining ACR 50 response after 16 weeks of therapy.

To identify predictors of DMARD response in patients with RA

Secondary outcome measures

Using ACR 50 composite measure, does evidence of co-morbid conditions (e.g. periodontal disease) predict DMARD response

Using ACR 50 composite measure, does the presence of certain genetic factors such as the shared epitope predict DMARD response

Using ACR 50 composite measure, does the presence of serological factors (e.g. CCP isotypes) predict DMARD response

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

539 Previous Clinical Trials

1,144,334 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment still taking place?

"That is correct, the listing on clinicaltrials.gov does show that this study is actively recruiting patients. The trial was first made public on August 1st, 2007 with the most recent update on October 28th, 2021. They are hoping to enroll 400 individuals at 1 location."

Answered by AI

To date, how many test subjects have signed up for this research project?

"Yes, the data on clinicaltrials.gov says that this clinical trial is actively recruiting candidates. The trial was originally posted on 8/1/2007 and was last updated on 10/28/2021. The clinical trial is admitting 400 patients at 1 sites."

Answered by AI

Has Methotrexate been cleared by the FDA for use as a treatment?

"There is some evidence gathered from previous clinical trials to support the efficacy of Methotrexate Therapy. Furthermore, this therapy has also undergone multiple rounds of testing to support its safety. Consequently, our team at Power has given it a safety score of 3."

Answered by AI