Is NCT06671054 recruiting in Duncansville, PA?

Yes, NCT06671054 is currently recruiting participants at its Duncansville, PA location. This rheumatoid arthritis (ra) clinical trial is actively enrolling qualified participants.

How do I join the rheumatoid arthritis (ra) clinical trial in Duncansville?

To join this clinical trial in Duncansville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Duncansville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Rheumatoid Arthritis (RA) Clinical Trial in Duncansville, PA

About This Rheumatoid Arthritis (RA) Study in Duncansville

The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.

Sponsor: SynAct Pharma Aps

Who Can Participate

Inclusion Criteria

Signed and dated informed consent obtained before undergoing any trial-specific procedure.

Participants with definite RA diagnosis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.

Disease duration no longer than 6 months from diagnosis at the time of Baseline Visit and with a history of RA symptoms which does not exceed 18 months.

Participants must be naïve to any Disease-modifying anti-rheumatic drugs (DMARDs)

Participants with at least 6/68 tender and 6/66 swollen joints at Screening Visit and Baseline.

Participants with "high" disease activity as documented by a Disease Activity Score 28 (DAS28) (C-Reactive Protein - CRP) index score \> 5.1 at screening, and Clinical disease activity index (CDAI) \>22 at Screening Visit and Baseline.

Participants with serum high sensitive C-Reactive Protein (hsCRP) ≥3 mg/L at the time of screening.

Participants positive for serum rheumatoid factor (RF), AND/OR anti-cyclic citrullinated peptide antibodies (anti-CCP). If seronegative RA, hsCRP ≥6 mg/L at the time of screening.

Willing and able to comply with the scheduled study visits, the treatment plan, and all study procedures.

Females of childbearing potential must have a negative pregnancy test at screening and again at baseline.

Sexually active female participants of childbearing potential and male participants are excluded if not practicing two different methods of birth control with their partner during the study and for 90 days after the last dose of study drug or who will not remain abstinent during the study and for 90 days after the last dose.

Exclusion Criteria

Functional class IV of Global Functional Status in RA, as defined by the ACR Classification.

Rheumatic autoimmune disease other than RA, i.e. systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to RA.

Current inflammatory joint disease other than RA.

Non-inflammatory type of musculoskeletal condition that in the Investigator's opinion is symptomatic and/or severe enough to interfere with the subject's primary diagnosis of RA or the evaluation of the effect of the study drug.

Gastrointestinal diseases known to interfere with the absorption or excretion of medications.

Severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.

Malignancy active during the 12 months preceding the Screening Visit.

Acute hepatitis, chronic hepatitis, or detection of any unexplained elevation of serum ALT or AST greater than 1.5-fold ULN, at least twice in the 6 months before the Screening Visit) or HIV infection.

History of alcohol or drug abuse during the 12 months preceding the Screening Visit.

Vaccination with live vaccines during the 6 weeks preceding the Screening Visit.

Haemoglobin \<9 g/dL or Haematocrit \<30% at the Screening Visit

White blood cell (WBC) count \<3.0 x 109/L at the Screening Visit.

Absolute neutrophil count \<1.2 x 109/L at the Screening Visit.

Platelet count \<100 x 109/L at the Screening Visit.

Serum alkaline-phosphatase, or gamma-glutamyl-transferase greater than 3-fold ULN; alanine aminotransferase, or aspartate aminotransferase, or total bilirubin greater than 2-fold ULN At the Screening Visit.

Estimated creatinine clearance less than 45 mL/min/1.73 m2 (MDRD) at the Screening Visit.

12-lead electrocardiogram (ECG) with abnormal clinically significant findings, as judged by the Investigator, at the Screening Visit.

Positive QuantiFERON-in-Tube test (QFG-IT).

Use of hydroxychloroquine during the 30 weeks preceding the Screening Visit.

Treatment with any systemic or intraarticular corticosteroid within 6 weeks before the Screening Visit.

Intermittent use of nonsteroidal anti-inflammatory drugs (NSAIDs). Use of NSAIDs is allowed if used in a stable dose regimen for at least 4 weeks prior to the Screening Visit.

Use of other investigational drugs/treatments, or enrolment in a clinical trial during the 6 months preceding the Screening Visit.

Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject's safety during trial participation.

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 Duncansville?

Yes, this clinical trial (NCT06671054) has an active research site in Duncansville, PA 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 (RA) Treatment Options in Duncansville, PA

If you're searching for rheumatoid arthritis (ra) treatment options in Duncansville, PA, this clinical trial (NCT06671054) 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 Duncansville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced rheumatoid arthritis (ra) 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 (ra) clinical trials near you to find additional studies recruiting in your area.

Rheumatoid Arthritis (RA) Clinical Trial in Duncansville, PA

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