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Study of Oral AP1189 at 40, 70, or 100 mg with Methotrexate for 12 Weeks in Early Rheumatoid Arthritis A Randomized, Double Blind, Placebo-Controlled Trial in DMARD-Naive Participants
Led by SynAct Pharma Aps · Updated on 2025-10-06
240
Participants Needed
11
Research Sites
60 weeks
Total Duration
On this page
Sponsors
S
SynAct Pharma Aps
Lead Sponsor
N
NBCD A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of oral AP1189 combined with methotrexate (MTX) in adults with early rheumatoid arthritis (RA) who have not previously taken disease-modifying anti-rheumatic drugs (DMARDs). This phase II, randomized, double-blind, placebo-controlled study aims to understand how different doses of AP1189 affect disease activity and inflammation in participants with active RA symptoms. The study involves four groups of 60 participants each, receiving either AP1189 at doses of 40 mg, 70 mg, 100 mg, or a placebo, all alongside oral methotrexate. Treatments are given daily for 12 weeks. Participants will be randomly assigned to one of these groups to compare the dose response and safety of AP1189 combined with methotrexate versus methotrexate alone. Participants will attend scheduled visits to monitor their disease activity, safety, and tolerability of the treatment. Assessments include measuring changes in the Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) at week 12. The study also involves physical exams, joint assessments, blood tests for inflammation markers and antibodies, and safety monitoring. The total treatment period lasts 12 weeks, with ongoing evaluations throughout this time.
CONDITIONS
Official Title
A Dose Response Study to Evaluate the Efficacy and Safety of Oral AP1189 Administered in Disease-Modifying Anti-Rheumatic Drug (DMARD) naïve Participants Participants With Early Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent before any trial procedures
- Definite rheumatoid arthritis diagnosis by 2010 ACR/EULAR criteria
- Disease duration no longer than 6 months from diagnosis and RA symptoms not exceeding 18 months
- NaFve to any disease-modifying anti-rheumatic drugs (DMARDs)
- At least 6 tender and 6 swollen joints at screening and baseline
- High disease activity with DAS28-CRP score > 5.1 and CDAI > 22 at screening and baseline
- Serum high sensitive C-Reactive Protein (hsCRP) 63 mg/L at screening
- Positive for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibodies (anti-CCP), or if seronegative RA, hsCRP 66 mg/L at screening
- Willing and able to comply with study visits, treatment, and procedures
- Females of childbearing potential must have negative pregnancy tests at screening and baseline
- Sexually active females and males must practice two methods of birth control or remain abstinent during the study and for 90 days after last dose
You will not qualify if you...
- Functional class IV of Global Functional Status in RA
- Other rheumatic autoimmune diseases besides RA
- Current inflammatory joint disease other than RA
- Non-inflammatory musculoskeletal conditions that interfere with RA diagnosis or study evaluation
- Gastrointestinal diseases affecting medication absorption or excretion
- Severe or uncontrolled major organ diseases
- Active malignancy within 12 months before screening
- Acute or chronic hepatitis, unexplained liver enzyme elevations, or HIV infection
- History of alcohol or drug abuse within 12 months before screening
- Live vaccinations within 6 weeks before screening
- Hemoglobin <9 g/dL or hematocrit <30% at screening
- White blood cell count <3.0 x 10^9/L at screening
- Absolute neutrophil count <1.2 x 10^9/L at screening
- Platelet count <100 x 10^9/L at screening
- Liver enzymes or bilirubin above specified limits at screening
- Estimated creatinine clearance less than 45 mL/min/1.73 m2 at screening
- Abnormal clinically significant ECG findings at screening
- Positive QuantiFERON-in-Tube test
- Hydroxychloroquine use within 30 weeks before screening
- Systemic or intraarticular corticosteroid treatment within 6 weeks before screening
- Unstable or intermittent NSAID use; stable NSAID use for at least 4 weeks allowed
- Use of investigational drugs or enrollment in clinical trials within 6 months before screening
- Any other clinical condition that may affect safety or study assessments
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Nouvelle Clinical Research LLC
Cutler Bay, Florida, United States, 33189
Actively Recruiting
2
Millennium Medical Research LLC
Miami, Florida, United States, 33126
Actively Recruiting
3
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
4
Diagnostic Consultative Center Aleksandrovska
Sofia, Bulgaria, 1431
Actively Recruiting
5
Medical Center Tera Medico
Vratsa, Bulgaria, 3000
Actively Recruiting
6
Sanos Clinic Herlev
Herlev, Denmark, 2730
Actively Recruiting
7
IMSP Spitalul Clinic Municipal "Sfanta Treime"
Chisinau, Moldova, 2068
Actively Recruiting
8
M2Mmed
Chorzów, Poland, 41-500
Actively Recruiting
9
Vita Longa Sp. z o. o.
Katowice, Poland, 41-500
Actively Recruiting
10
Medyczne Centrum Hetmańska
Poznan, Poland, 60-218
Actively Recruiting
11
DC-MED Michal Kowalski S.K.
Swidnica, Poland, 58-100
Actively Recruiting
Research Team
T
Thomas Jonassen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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