Phase 2 Rheumatoid Arthritis Trial, Recruiting NCT07137598 Sponsor: Hoffmann-La Roche Condition: Rheumatoid Arthritis
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Phase 2 Rheumatoid Arthritis Trial, Recruiting

NCT07137598
Recruiting Phase 2

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 have moderate to severe active rheumatoid arthritis (RA), with at least 6 swollen joints and at least 6 tender joints measured at two separate check-in appointments.
  • People who have had a formal diagnosis of RA for at least 3 months, and whose diagnosis meets the 2010 international classification standards for RA.
  • People whose RA did not respond well enough to, stopped responding to, or who could not tolerate at least one standard RA medication (known as a conventional DMARD).

Who may not be able to join:

  • People who have already tried and not responded to more than two TNF inhibitor or JAK inhibitor medications.
  • People whose RA is classified as the most severe functional stage (Class IV), meaning they have very limited ability to perform self-care, work, or other activities.
  • People who have previously used or are currently using certain biological RA medications (called bDMARDs), other than TNF inhibitors, or who have been treated with rituximab.
  • People who have taken part in another clinical trial and received an experimental treatment within the past 4 weeks, or within 5 half-lives of that treatment, whichever period is longer.
  • People who have a history of any form of arthritis that started before age 17, or who currently have a different type of inflammatory joint condition other than RA.
  • People who have received corticosteroid injections (into a joint, muscle, vein, or surrounding tissue) within the 8 weeks before the first dose of the trial drug.
  • People with a history of a severe allergic or anaphylactic reaction, or a known sensitivity to any ingredient in the trial drug or other medications in the same class.
  • People who have had major surgery within 6 weeks before the screening appointment, or who have major surgery planned during the trial period.
  • People who have a serious, long-term, or unstable medical or psychiatric condition of any kind.
  • People with a history of cancer, except for certain treated and resolved skin cancers (such as basal cell carcinoma or squamous cell skin cancer) or fully treated and cleared cervical cancer in situ.
  • People who have severe, ongoing, or frequently recurring infections caused by viruses, bacteria, parasites, or fungi.
  • People with a history of active hepatitis B, hepatitis C, or HIV infection.
  • People who have had an organ transplant.
  • People with a confirmed inherited or acquired immune system deficiency.
  • People with abnormal blood test results or abnormal liver function test results (confirm with trial site for specific thresholds).

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 19 July 2026
Phase 2: approximately ~30% 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

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Phone: 888-662-6728 (U.S. and Canada)

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
5 December 2025
Est. completion
19 April 2027

Where this trial is recruiting

🇦🇷 Argentina 🇧🇪 Belgium 🇧🇷 Brazil 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇵🇱 Poland 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP)

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: 19 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