Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial

To be considered for this study, you need to be at least 18 years old and have Crohn's disease that has been active for at least six weeks. Your doctor will use specific ways to check if your disease is active enough to join, including looking at your symptoms and checking for inflammation in your gut during a procedure called an endoscopy. You would also need to be starting treatment with adalimumab because your current treatments haven't worked well enough, or you can't take them.

There are also some reasons why you might not be able to join. For example, if you've had certain surgeries recently, have severe bowel blockages, or have had a bad reaction to similar medicines in the past, you wouldn't be eligible. The study also cannot include pregnant or breastfeeding women, or those planning a pregnancy; all women and men who could have children must use reliable birth control methods during the study.

Finally, you can't have previously taken adalimumab, or currently be taking any other experimental medications. Anyone with serious existing illnesses that could interfere with the study, or those considered 'protected by law' (which can include people in certain care situations), would also not be able to participate. You must also be followed by a hospital that is part of the GETAID network and provide your written consent to join.

If you choose to take part in this study, you would receive either azathioprine capsules or methotrexate (the specific form of methotrexate isn't detailed, but it's often given as a tablet or injection), both in combination with adalimumab. The study is "open-label," meaning both you and your doctors will know which treatment you are receiving.

Taking part would involve regular visits to your study centre. During these visits, the medical team will monitor your health closely, check your symptoms, and possibly take blood samples to see how your body is reacting to the treatment and to measure medication levels. They will also perform endoscopies to check for healing in your gut at specific points during the study.

The exact number and timing of visits, as well as the total length of your participation, aren't specified in detail here, but such studies typically involve follow-up over several months to assess the short-term outcomes. You would need to follow specific instructions for taking your medication and use effective birth control if applicable.