Phase 3 Rheumatoid Arthritis Trial, Recruiting NCT06596772 Sponsor: mAbxience Research S.L. Condition: Rheumatoid Arthritis
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Phase 3 Rheumatoid Arthritis Trial, Recruiting

NCT06596772
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who were diagnosed with rheumatoid arthritis (RA) at least 6 months ago but no more than 15 years ago, based on recognised medical criteria.
  • People who still have moderate to severe RA symptoms despite taking methotrexate (MTX), meaning they have 6 or more swollen joints and 6 or more tender joints, plus elevated inflammation markers in their blood and a positive RA-related blood test result.
  • People who have been taking a stable dose of methotrexate (between 10 and 25 mg per week) for at least 12 weeks, with no dose changes in the 8 weeks before joining the trial.
  • People who have been on a stable dose of anti-inflammatory or pain relief medications for at least 4 weeks before joining the trial, if these medications are being used.
  • People who have been taking a stable low dose of steroid medication (no more than 10 mg of prednisone or equivalent per day) for at least 4 weeks before joining the trial, if steroids are being used.
  • People who are considered generally medically stable, as assessed by the treating doctor.
  • People who agree to use highly effective contraception for up to 6 months after the last dose of the study drug.

Who may not be able to join:

  • People who have previously been treated with a biologic or targeted synthetic disease-modifying medication (a specific class of RA treatments).
  • People who have previously been treated with a monoclonal antibody medication for any condition other than RA.
  • People who have a known allergy or sensitivity to any ingredient in the study drug or the prefilled syringe used to deliver it.
  • People whose arthritis began before the age of 16, or who currently have a different type of inflammatory joint disease other than RA.
  • People who have serious body-wide complications from RA, beyond rheumatoid nodules or a secondary dry eye/dry mouth condition (secondary Sjögren's syndrome).
  • People with an active infection or infections that could return and cause serious illness. (Note: people found to have latent tuberculosis during screening may be able to be re-screened after starting an approved treatment — confirm with trial site.)
  • People who have had a solid organ or blood cancer within the past 5 years.
  • People who are currently pregnant or breastfeeding.
  • People who have any other medical condition that the treating doctor believes could affect their safety, their ability to participate, or the reliability of the trial results.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +34-917-711-500

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
mAbxience Research S.L.
Registry
ClinicalTrials.gov
Start date
3 October 2024
Est. completion
1 October 2025

Where this trial is recruiting

🇧🇬 Bulgaria 🇬🇪 Georgia Moldova 🇵🇱 Poland 🇷🇴 Romania 🇷🇸 Serbia

Primary endpoints

American College of Rheumatology 20% Response Criteria (ACR20)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov