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

Must not be taking: Biologics, Steroids

Disqualifiers: Other arthritis, Fibromyalgia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

300 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

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

Group I: MRC375 75 mg Experimental Treatment 1 Intervention

MRC375 (enteric coated Tetracycline) 75 mg 3 times a day

Group II: MRC375 150mg Experimental Treatment 1 Intervention

MRC375 (enteric coated Tetracycline) 150mg 3 times a day for 24 weeks.

Group III: Placebo Placebo Group 1 Intervention

Placebo

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. United States pubmed.ncbi.nlm.nih.gov

New Associations between Drug-Induced Adverse Events in Animal Models and Humans Reveal Novel Candidate Safety Targets. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Manipulation of zebrafish embryogenesis by phosphorodiamidate morpholino oligomers indicates minimal non-specific teratogenesis. [2011]

4. England pubmed.ncbi.nlm.nih.gov

In vitro safety pharmacology profiling: what else beyond hERG? [2016]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Musculoskeletal adverse drug reactions: a review of literature and data from ADR spontaneous reporting databases. [2019]

6. England pubmed.ncbi.nlm.nih.gov

MORC protein family-related signature within human disease and cancer. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Emerging Role of MORC Family Proteins in Cancer Development and Bone Homeostasis. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Mutation of the MXI1 gene in prostate cancer. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Multivalent Chromatin Engagement and Inter-domain Crosstalk Regulate MORC3 ATPase. [2020]