300 Participants Needed

A Study of Two Doses of MRC375 in Moderate to Severe Rheumatoid Arthritis Patients

Recruiting at 18 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Molecular Research Center, Inc.
Must be taking: Methotrexate, NSAIDs
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop taking my current medications to join the trial?

You may need to stop some of your current medications to join the trial, but you can continue taking low doses of methotrexate, NSAIDs, or hydroxychloroquine if they are stable. Other medications like certain biologics and steroids must be stopped for a specific period before starting the trial.

Is the treatment MRC375 generally safe for humans?

Research on phosphorodiamidate morpholino oligomers (PMOs), which may be related to MRC375, shows minimal risk of causing birth defects, with only 0.3% of cases showing potential issues in studies involving over 47,000 embryos. This suggests a low risk of serious side effects in humans.12345

How does the drug MRC375 differ from other treatments for this condition?

MRC375 is unique because it involves the MORC family of proteins, which are known for their role in chromatin remodeling and epigenetic regulation, potentially making it a novel approach in targeting diseases where these processes are disrupted. This mechanism is different from many traditional treatments that may not target these specific pathways.678910

What is the purpose of this trial?

This trial tests MRC375, a pill taken regularly, in adults with moderate to severe rheumatoid arthritis. The medication might help reduce joint inflammation and pain by using an ingredient that can also fight bacteria.

Eligibility Criteria

Inclusion Criteria

≥4 tender joints/painful (28 joint count) at screening
≥4 swollen joints (28 joint count) at screening
Has a Health Assessment Questionnaire (HAQ) of >0
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MRC375 or placebo for 24 weeks to assess safety and efficacy in moderate to severe rheumatoid arthritis

24 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • MRC375
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: MRC375 75 mgExperimental Treatment1 Intervention
MRC375 (enteric coated Tetracycline) 75 mg 3 times a day
Group II: MRC375 150mgExperimental Treatment1 Intervention
MRC375 (enteric coated Tetracycline) 150mg 3 times a day for 24 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Molecular Research Center, Inc.

Lead Sponsor

Trials
1
Recruited
300+

Bilcare Global Clinical Supplies

Collaborator

Trials
1
Recruited
300+

Harrison Clinical Research

Industry Sponsor

Trials
6
Recruited
1,400+

BARC Global Central Laboratory

Collaborator

Trials
1
Recruited
300+

Camargo Pharmaceutical Services

Industry Sponsor

Trials
3
Recruited
330+

Clin Data Services

Collaborator

Trials
1
Recruited
300+

Findings from Research

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.
The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.
Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs.Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]
Musculoskeletal adverse drug reactions (ADRs) can range from mild issues like muscle cramps to severe conditions such as rhabdomyolysis, highlighting the importance of monitoring drug safety.
Recent analyses of drug classes, including statins and fluoroquinolones, revealed a significant association with serious musculoskeletal injuries, emphasizing the need for awareness and further investigation into the mechanisms behind these ADRs.
Musculoskeletal adverse drug reactions: a review of literature and data from ADR spontaneous reporting databases.Conforti, A., Chiamulera, C., Moretti, U., et al.[2019]

References

New Associations between Drug-Induced Adverse Events in Animal Models and Humans Reveal Novel Candidate Safety Targets. [2021]
Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]
Manipulation of zebrafish embryogenesis by phosphorodiamidate morpholino oligomers indicates minimal non-specific teratogenesis. [2011]
In vitro safety pharmacology profiling: what else beyond hERG? [2016]
5.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Musculoskeletal adverse drug reactions: a review of literature and data from ADR spontaneous reporting databases. [2019]
MORC protein family-related signature within human disease and cancer. [2023]
The Emerging Role of MORC Family Proteins in Cancer Development and Bone Homeostasis. [2018]
Mutation of the MXI1 gene in prostate cancer. [2022]
Interaction of Myc-associated zinc finger protein with DCC, the product of a tumor-suppressor gene, during the neural differentiation of P19 EC cells. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Multivalent Chromatin Engagement and Inter-domain Crosstalk Regulate MORC3 ATPase. [2020]
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