Phase 4 Rheumatoid Arthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older who are able to understand and sign a consent form, and who can read and communicate well enough in the local language to follow the study steps
• People who have been diagnosed with rheumatoid arthritis (RA) based on established international classification criteria
• People who have been taking methotrexate tablets at a dose between 10mg and 25mg per week for at least 3 months, with the dose staying the same and being well tolerated for at least 12 weeks
• People whose RA is not fully controlled, shown by a disease activity score above a certain level and at least one visibly swollen joint
• People who are willing to have their methotrexate dose increased and to change the way it is given, as required by the study

Who may not be able to join:

• People who have an inflammatory joint or rheumatic disease other than rheumatoid arthritis
• People who have ever taken, or are currently taking, certain types of stronger arthritis medicines called biological or targeted treatments, or any other conventional arthritis medicine apart from methotrexate or hydroxychloroquine
• People taking steroid medicines (such as prednisone), unless the dose has been stable at 10mg or less per day for at least 4 weeks before joining
• People taking anti-inflammatory pain medicines (NSAIDs), unless the dose has been stable for at least 2 weeks before joining
• People who have had a steroid injection directly into a joint within the past 8 weeks
• People who have had significant side effects from methotrexate, as assessed by the study doctor
• People with liver enzyme levels in their blood that are more than twice the normal range
• People with reduced kidney function below a certain level
• People with certain blood count abnormalities, including moderate or more severe anaemia, low white blood cell count, or low platelet count
• People who have developed mouth sores as a side effect of methotrexate
• People who have had repeated or serious infections in the past two months, such as hepatitis, pneumonia, or a severe kidney infection
• People who test positive for hepatitis B or hepatitis C at the screening visit
• People who have ongoing or recurring serious infections such as shingles, certain fungal infections, or tuberculosis-related conditions, as assessed by the study doctor
• Women who are able to become pregnant and are not using an adequate and reliable form of contraception, or who are not willing to continue using contraception throughout the study and for 6 months after the last dose
• People with severe, worsening, or uncontrolled disease affecting the kidneys, liver, blood, digestive system, hormones, lungs, heart, nerves, or brain, as assessed by the study doctor
• People who are unable or unwilling to have multiple blood draws due to poor tolerance or difficulty accessing veins
• People who are unwilling or unable to self-administer injections under the skin
• People who have received a transplanted organ (other than a corneal transplant that took place more than 3 months before screening)
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after completing the study
• People who have had a problem with alcohol or substance misuse in the past 6 months
• People with any medical or psychological condition that the study doctor considers would make it unsafe for them to complete the trial
• People who have received a live or weakened live vaccine within 12 weeks before the study start, or who may need one during the study
• People who are currently taking part in another clinical intervention study

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