Centennial, CONCT07704580Now EnrollingIRB Ready

Rheumatoid Arthritis Clinical Trial in Centennial, CO

Access cutting-edge rheumatoid arthritis treatment through this phase 1/2 clinical trial at a research site in Centennial. Study-provided care at no cost to qualified participants.

Sponsored by Sanofi

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Expert Care in Centennial

Access rheumatoid arthritis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related rheumatoid arthritis treatment provided free

Apply for This Centennial Location

Check if you qualify for this rheumatoid arthritis clinical trial in Centennial, CO

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Why Participate?

  • No-Cost Study Care

  • Local to Centennial

    Convenient for CO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Centennial site if eligible
  4. 4Begin participation

About This Rheumatoid Arthritis Study in Centennial

This is a Phase 1/Phase 2 study with: * 5-arms design for Part A; * and a single arm for Part B. The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older. Study details include: * The study duration will be up to 64 weeks. * The treatment duration will be up to 6 months for each study phase. * Part A has 10 visits, including a post-treatment end of study (EOS) follow-up visit. * For participants entering the open label extension to receive the approved 200 mg sarilumab every two weeks (Q2W) dose, there will be 3 additional study visits. * For the intra-study sarilumab 200 mg Q2W subcutaneous (SC) arm, participants will be evaluated over the course of 24 weeks plus post-treatment EOS follow-up visit following the schedule of activities (SoA) of Part A from Day -1 to Day 29 (total of 8 visits) and the SoA of Part B from Week 4 to Week 24 (total of 8 visits) and a post-treatment end of study (EOS) follow-up visit at Week 30 (Part B) for a total of 17 visits, including a post-treatment EOS follow-up visit. * Part B has 13 visits, including a post-treatment EOS follow-up visit.

Sponsor: Sanofi

Who Can Participate

Inclusion Criteria

Participant must be 18 years old or the legal age of consent in the jurisdiction in which the study is taking place or older, at the time of signing the informed consent.
Diagnosis of RA, according to the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) 2010 RA Classification Criteria with ≥3 months disease duration.
ACR Class I to III functional status, based on the 1991 revised criteria
Moderate-to-severely active RA, defined as: DAS28-ESR\>3.2.
Inability to continue treatment with a RA DMARD approved for first line use because of intolerance or inadequate response.
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria

Any prior (within the defined periods below) or concurrent use of immunosuppressive:
Janus kinase (JAK) inhibitor (eg, tofacitinib) within 4 weeks of baseline.
Cell-depletion agents (eg, anti CD20) without evidence of recovery of B cells to baseline level.
Anakinra within 1 week of baseline.
Abatacept within 8 weeks of baseline.
Tumor necrosis factor (TNF) inhibitors within 2 to 8 weeks.
Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline.
Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.
Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological IL-6 antagonist (prior IL-6 antagonist treatment that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).
Unstable methotrexate (MTX) dose (if participant is on concomitant MTX).
Concurrent use of systemic corticosteroids (CS) of more than 10 mg/day.
Pregnant or breastfeeding woman.
History of invasive opportunistic infections, including but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis despite resolution or John Cunningham virus (progressive multifocal leukoencephalopathy).
Uncontrolled diabetes mellitus.
History of prior articular or prosthetic joint infection.
Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the baseline visit.
History of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.
History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
Severe systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Centennial?

Yes, this clinical trial (NCT07704580) has an active research site in Centennial, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Rheumatoid Arthritis Treatment Options in Centennial, CO

If you're searching for rheumatoid arthritis treatment options in Centennial, CO, this clinical trial (NCT07704580) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Centennial research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced rheumatoid arthritis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all rheumatoid arthritis clinical trials near you to find additional studies recruiting in your area.

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