Phase 3 Rheumatoid Arthritis Trial, Completed NCT00422383 Sponsor: Hoffmann-La Roche Condition: Rheumatoid Arthritis
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial looked at different doses of a medicine called rituximab, always given together with another medicine called methotrexate, in people with rheumatoid arthritis. There were five groups in the trial: a low dose group (134 participants), an escalated dose group (120 participants), a high dose group (93 participants), a placebo/rituximab group (6 participants), and a decreased dose group (25 participants). The trial measured how participants' joint symptoms and overall disease activity changed over approximately 48 weeks (about one year). The reported data shows that for the main outcome — the percentage of participants who showed at least a 20% improvement in a standard joint assessment score (known as ACR20) — the figures were 64.2% in the low dose group, 63.9% in the escalated dose group, and 72.0% in the high dose group. For a higher bar of 50% improvement (ACR50), the reported figures were 39%, 39%, and 48% respectively, and for a 70% improvement bar (ACR70), they were 20%, 19%, and 23%. A separate disease activity score (rated on a scale where higher numbers mean more active disease) was also reported to have decreased from the starting point by around 2.1 to 2.4 points across the three main groups. For a fatigue questionnaire scored from 0 to 52, the reported changes from the starting point ranged from approximately 2.0 to 8.4 points across all five groups, where a positive number indicates a change in the direction of less fatigue. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Rheumatoid Arthritis Trial, Completed

NCT00422383
Completed Phase 3 🇦🇺 Australian site

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:

  • You are 18 years of age or older
  • You have been diagnosed with rheumatoid arthritis (RA) for at least 6 months
  • You are receiving treatment as an outpatient (not staying in hospital)
  • You have been taking methotrexate for at least 12 weeks, have tolerated it, and have been on the same dose for at least 4 weeks without it working well enough

Who may not be able to join:

  • You have another autoimmune or rheumatic disease besides RA, or your RA has caused serious effects on major organs or body systems
  • You have another type of inflammatory joint disease or any other systemic (whole-body) autoimmune condition
  • You were diagnosed with juvenile arthritis, or you were first diagnosed with RA before the age of 16
  • You have previously been treated with more than one biologic medicine, have had any therapy that depletes certain immune cells, or are currently taking any biologic medicine or disease-modifying drug other than methotrexate

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 12 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

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Australian sites

, Coffs Harbour, New South Wales
, Sydney, New South Wales
, Maroochydore, Queensland
, Southport, Queensland
, Malvern, Victoria
, Melbourne, Victoria

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

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 February 2006
Est. completion
1 March 2013

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇿 New Zealand 🇸🇰 Slovakia 🇿🇦 South Africa 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand 🇬🇧 United Kingdom

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (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: 12 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