AP1189 + Methotrexate for Rheumatoid Arthritis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: SynAct Pharma Aps
Must be taking: Methotrexate
Must not be taking: Corticosteroids, Hydroxychloroquine
Disqualifiers: Other autoimmune diseases, Malignancy, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires participants to be naïve to any Disease-modifying anti-rheumatic drugs (DMARDs) and not to have used hydroxychloroquine in the 30 weeks before the Screening Visit. Participants must also not have used systemic or intraarticular corticosteroids within 6 weeks before the Screening Visit. NSAIDs can be used if they have been taken in a stable dose for at least 4 weeks prior to the Screening Visit.
What data supports the effectiveness of the drug AP1189 + Methotrexate for Rheumatoid Arthritis?
What is known about the safety of methotrexate in treating rheumatoid arthritis?
What makes the drug AP1189 + Methotrexate unique for treating rheumatoid arthritis?
AP1189 (Resomelagon) combined with Methotrexate offers a novel approach by potentially enhancing the anti-inflammatory effects of Methotrexate, which is already a well-established treatment for rheumatoid arthritis. This combination could provide improved outcomes for patients who do not respond adequately to Methotrexate alone.711121314
Research Team
Eligibility Criteria
This trial is for people who have just been diagnosed with early rheumatoid arthritis and haven't taken any disease-modifying anti-rheumatic drugs (DMARDs) yet. They should be experiencing active inflammation but can't join if they've had certain other treatments or health conditions that the study details exclude.Inclusion Criteria
Participants with serum high sensitive C-Reactive Protein (hsCRP) ≥3 mg/L at the time of screening
My arthritis is very active, with high scores on specific health tests.
I have rheumatoid arthritis with positive RF or anti-CCP, or my hsCRP levels are ≥6 mg/L.
See 8 more
Exclusion Criteria
I have a joint or muscle condition that affects my rheumatoid arthritis or how drugs work for me.
Functional class IV of Global Functional Status in RA, as defined by the ACR Classification
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
See 20 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive daily treatment of oral AP1189 at doses of 40, 70, or 100 mg in combination with Methotrexate for 12 weeks
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- AP1189 (Other)
Trial OverviewThe trial is testing different doses of a new pill, AP1189, to see how well it works and how safe it is when given alongside methotrexate, a common medication for rheumatoid arthritis. Participants will randomly receive either 40 mg, 70 mg, or 100 mg of AP1189 or a placebo without knowing which one they're getting.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
12 weeks daily treatment of oral AP1189 matching placebo as add-on to Methotrexate (MTX)
Group II: AP1189 70 mgExperimental Treatment1 Intervention
12 weeks daily treatment of oral AP1189 70 mg as add-on to Methotrexate (MTX)
Group III: AP1189 40 mgExperimental Treatment1 Intervention
12 weeks daily treatment of oral AP1189 40 mg as add-on to Methotrexate (MTX)
Group IV: AP1189 100 mgExperimental Treatment1 Intervention
12 weeks daily treatment of oral AP1189 100 mg as add-on to Methotrexate (MTX)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Altoona Center for Clinical ResearchDuncansville, PA
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Who Is Running the Clinical Trial?
SynAct Pharma Aps
Lead Sponsor
Trials
5
Patients Recruited
620+
NBCD A/S
Industry Sponsor
Trials
11
Patients Recruited
2,300+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Etanercept: a review of its use in rheumatoid arthritis.Jarvis, B., Faulds, D.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Comparison between low disease activity or DAS remission as treatment target in patients with early active rheumatoid arthritis.Akdemir, G., Markusse, IM., Bergstra, SA., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Clinical remission and/or minimal disease activity in patients receiving adalimumab treatment in a multinational, open-label, twelve-week study.Burmester, GR., Ferraccioli, G., Flipo, RM., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Patient-reported health outcomes in a trial of etanercept monotherapy versus combination therapy with etanercept and methotrexate for rheumatoid arthritis: the ADORE trial.van Riel, PL., Freundlich, B., MacPeek, D., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Comparative effectiveness and survival of infliximab, adalimumab, and etanercept for rheumatoid arthritis patients in the Hellenic Registry of Biologics: Low rates of remission and 5-year drug survival.Flouri, I., Markatseli, TE., Voulgari, PV., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Low-dose methotrexate in rheumatic diseases--efficacy, side effects, and risk factors for side effects.Schnabel, A., Gross, WL.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Methotrexate: its use in the rheumatic diseases.Bookbinder, SA., Espinoza, LR., Fenske, NA., et al.[2017]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy, safety and immunogenicity of etanercept biosimilars versus reference biologics in patients with rheumatoid arthritis: A meta-analysis.Hu, R., Yuan, T., Wang, H., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Methotrexate in rheumatoid arthritis].Alamo, M., Grisanti, M.[2013]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Search of official nationwide database in Japan for adverse events associated with disease-modifying antirheumatic drug therapies: focus on therapies in combination with methotrexate.Inokuma, S.[2022]
Methotrexate is an effective treatment for refractory rheumatoid arthritis, showing early symptomatic improvement in most patients and having one of the best efficacy-toxicity ratios among slow-acting antirheumatic agents, based on early placebo-controlled trials and meta-analyses.
The drug acts primarily as an anti-inflammatory agent with immunomodulating properties, although its exact mechanism in rheumatoid arthritis is not fully understood; it is mainly excreted by the kidneys and has significant interindividual variation in bioavailability.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Methotrexate in rheumatoid arthritis. An update.Bannwarth, B., Labat, L., Moride, Y., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Weekly low-dose methotrexate in rheumatoid arthritis. Review of the literature].Manganelli, P., Troise Rioda, W.[2016]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Does the p38 MAP kinase inhibitor pamapimod have potential for the treatment of rheumatoid arthritis?Doggrell, SA., Christensen, AM.[2010]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Methotrexate as the "anchor drug" for the treatment of early rheumatoid arthritis.Pincus, T., Yazici, Y., Sokka, T., et al.[2022]
References
Etanercept: a review of its use in rheumatoid arthritis. [2018]
Comparison between low disease activity or DAS remission as treatment target in patients with early active rheumatoid arthritis. [2022]
Clinical remission and/or minimal disease activity in patients receiving adalimumab treatment in a multinational, open-label, twelve-week study. [2022]
Patient-reported health outcomes in a trial of etanercept monotherapy versus combination therapy with etanercept and methotrexate for rheumatoid arthritis: the ADORE trial. [2022]
Comparative effectiveness and survival of infliximab, adalimumab, and etanercept for rheumatoid arthritis patients in the Hellenic Registry of Biologics: Low rates of remission and 5-year drug survival. [2022]
Low-dose methotrexate in rheumatic diseases--efficacy, side effects, and risk factors for side effects. [2022]
Methotrexate: its use in the rheumatic diseases. [2017]
Efficacy, safety and immunogenicity of etanercept biosimilars versus reference biologics in patients with rheumatoid arthritis: A meta-analysis. [2023]
[Methotrexate in rheumatoid arthritis]. [2013]
Search of official nationwide database in Japan for adverse events associated with disease-modifying antirheumatic drug therapies: focus on therapies in combination with methotrexate. [2022]
Methotrexate in rheumatoid arthritis. An update. [2018]
[Weekly low-dose methotrexate in rheumatoid arthritis. Review of the literature]. [2016]
Does the p38 MAP kinase inhibitor pamapimod have potential for the treatment of rheumatoid arthritis? [2010]
Methotrexate as the "anchor drug" for the treatment of early rheumatoid arthritis. [2022]