MRC375 for Rheumatoid Arthritis

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MRC375 for individuals with moderate to severe rheumatoid arthritis, a condition that causes joint pain and swelling. Participants will receive either a low or high dose of the drug or a placebo (a pill with no active medicine) to evaluate the treatment's effectiveness and safety. The trial includes up to 8 clinic visits over 24 weeks. Individuals who have had rheumatoid arthritis for more than 6 months and experience frequent joint pain and swelling might be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of potentially effective therapies.

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 there any evidence suggesting that MRC375 is likely to be safe for humans?

Research has shown that MRC375, a special form of the antibiotic tetracycline, presents some safety concerns. Long-term use of tetracycline can potentially affect the stomach, nervous system, skin, and teeth. It may also cause skin irritation or stomach issues when ingested.

Some individuals may be allergic to tetracyclines, so it is important to be aware of any previous reactions. Although these concerns might seem worrying, the study is at a stage where researchers closely monitor safety. They are carefully observing for any side effects to ensure the treatment remains as safe as possible. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for rheumatoid arthritis?

Researchers are excited about MRC375 for rheumatoid arthritis because it offers a novel approach by using enteric coated tetracycline, which is not typically used for this condition. Most rheumatoid arthritis treatments involve immunosuppressants like methotrexate or biologics targeting specific immune pathways. However, MRC375 could work differently, potentially reducing inflammation through its antibiotic properties with less focus on immune suppression. Additionally, the enteric coating allows MRC375 to be absorbed in the intestines, possibly reducing stomach irritation, a common issue with other oral medications.

What evidence suggests that MRC375 might be an effective treatment for rheumatoid arthritis?

Research has shown that tetracyclines, such as MRC375, may help treat infections and reduce inflammation. Studies on these advanced tetracyclines report a high success rate in clearing infections. The special coating on MRC375 prevents stomach issues. Additionally, tetracyclines can reduce certain bacteria that cause inflammation. This trial will evaluate MRC375 at two dosages, 75 mg and 150 mg, to assess its effectiveness in managing symptoms of rheumatoid arthritis, an inflammatory condition. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MRC375

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11531826/

Clinically important interactions of macrolides and ... We conducted a systematic review to assess the impact of dietary interventions on the bioavailability of 15 macrolides and 10 tetracyclines.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2923949/

Use of Oral Doxycycline for Community-acquired ... Ninety-six percent of patients (86/90) treated with an extended-spectrum tetracycline achieved success with resolution of their CA-MRSA infection, as compared ...

3. journals.sagepub.com journals.sagepub.com/doi/10.4137/CMT.S2035

Safety and Efficacy Review of Doxycycline Enteric-coated pellets have fewer gastrointestinal side effects. Photosensitivity can be prevented or ameliorated with adequate attention to sun ...

4. jcadonline.com jcadonline.com/sarecycline-narrow-spectrum-tetracycline-concept/

Sarecycline and the Narrow-spectrum Tetracycline Concept The available data on oral sarecycline use for treatment of acne in RCTs supports both efficacy and favorable safety, including a very low incidence of AEs ...

5. mdpi.com mdpi.com/2079-6382/10/8/886

Impact of Chronic Tetracycline Exposure on Human ... Exposure to 150 µg/mL tetracycline resulted in a decrease of total anaerobic bacteria from 1.9 × 107 ± 0.3 × 107 down to 2 × 106 ± 0.8 × 106 CFU/mL. Dose- ...

6. merck.com merck.com/docs/product/safety-data-sheets/ah-sds/Tetracycline%20Hydrochloride_AH_CA_EN.pdf

SAFETY DATA SHEET Tetracycline Hydrochloride May cause damage to organs (Gastrointestinal tract, Nervous system, Skin, Teeth) through pro- longed or repeated exposure if swallowed. Components: ...

7. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/14328m.pdf

Tetracycline (hydrochloride) Trade name: Tetracycline (hydrochloride)​​ Acute toxicity - oral 4 H302 Harmful if swallowed. Skin irritation 2 H315 Causes skin irritation.

8. fishersci.com fishersci.com/store/msds?partNumber=AC233100025&productDescription=TETRACYCLINE+HYDROCHLORI+2.5GR&vendorId=VN00032119&countryCode=US&language=en

SAFETY DATA SHEET Wear appropriate protective gloves and clothing to prevent skin exposure. Page 4. Tetracycline hydrochloride. Revision Date 24-Dec-2021.

9. sigmaaldrich.com sigmaaldrich.com/sds/sigma/t7660?srsltid=AfmBOoq1bP7hEqHaWwhaORtnufSPN0-AxRI5zz3pot57bSeth3OyiBP5

SAFETY DATA SHEET Suspected of damaging fertility. Specific target organ toxicity - single exposure. May cause respiratory irritation. Specific target organ ...

10. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c522c860-84ce-4c61-ab72-077de73195df

Label: TETRACYCLINE HYDROCHLORIDE tablet, film coated This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.