Phase 3 Rheumatoid Arthritis Trial, Completed NCT01197521 Sponsor: AstraZeneca 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 enrolled 918 people across three groups. One group (310 people) took fostamatinib 100 mg twice a day by mouth throughout the study. A second group (304 people) started on fostamatinib 100 mg twice a day, then switched to 150 mg once a day after four weeks. A third group (304 people) took a placebo (a dummy tablet with no active ingredient) for 24 weeks, then switched to fostamatinib 100 mg twice a day. The trial was measuring how well fostamatinib reduced signs of rheumatoid arthritis activity compared to placebo, and whether it slowed joint damage visible on X-rays, over 24 weeks. The reported data shows that at the 24-week mark, 49% of people in the first fostamatinib group and 44.4% in the second fostamatinib group met the trial's main measure of improvement in joint symptoms — compared with 34.2% in the placebo group. For joint damage visible on X-rays (scored on a scale of 0 to 448, where higher numbers mean more damage), the reported average change from the start of the trial was 0.45 points in the first fostamatinib group and 1.29 points in the second, compared with 0.13 points in the placebo group. For secondary measures, the reported data shows that after just one week, about 18.2% of combined fostamatinib participants met the improvement threshold, versus 4.9% in the placebo group. At 24 weeks, the proportions meeting higher improvement thresholds (a 50% or 70% improvement in symptoms) were also reported as higher in the fostamatinib groups than in the placebo group. The reported data also shows an overall average symptom improvement score at 24 weeks of 26.1% for the first fostamatinib group and 20.1% for the second, compared with 12.9% for the placebo group. These numbers describe what was measured and recorded in this trial; they do not account for individual variation between patients, and not all participants completed the study. 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

NCT01197521
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 have been diagnosed with rheumatoid arthritis (RA), and you were at least 16 years old when you were diagnosed
  • You are currently taking the medication methotrexate
  • You have 6 or more swollen joints AND 6 or more tender or painful joints, plus at least one of two specific blood test results showing signs of inflammation (confirm with trial site)
  • You have at least one of the following: a past or current positive blood test for rheumatoid factor, signs of joint damage seen on an X-ray within the last 12 months, or a positive blood test for a specific antibody linked to RA (anti-CCP antibodies)

Who may not be able to join:

  • You are currently pregnant or breastfeeding
  • You have high blood pressure that is not well controlled
  • You have liver disease or abnormal liver test results
  • You have certain other inflammatory conditions, connective tissue diseases, or long-term pain conditions (other than RA) (confirm with trial site)
  • You have a serious heart or blood vessel condition, either recent or ongoing
  • You have a significant active or recent infection, including tuberculosis
  • You have previously tried a type of medication called a TNF alpha antagonist or anakinra and it did not work for you, or you have previously been treated with certain other biological medicines
  • You have severely reduced kidney function
  • You have a low level of a type of white blood cell called neutrophils (confirm with trial site)

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 26 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: Neil MacKillop, MD PhD, AstraZeneca

Australian sites

Research Site, Camperdown, New South Wales
Research Site, Cairns, Queensland
Research Site, Southport, Queensland

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
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
1 September 2010
Est. completion
1 November 2012

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇱 Chile 🇪🇪 Estonia 🇫🇷 France 🇭🇺 Hungary 🇮🇳 India 🇲🇽 Mexico 🇵🇪 Peru 🇵🇱 Poland 🇸🇰 Slovakia 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.; Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.

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: 26 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