Outcomes | Measures | Time frame |
---|---|---|
Proportion of patients who are at acceptable therapeutic goal (SER)* | Acceptable therapeutic goal (SER)* | 1 year post-randomization (primary) |
- BASDAI <4 | End of study (secondary) | |
- Physician GA <4 | ||
- Patient GA <4 | ||
- Nocturnal axial pain <4 | ||
Proportion of patients who are at ideal therapeutic goal (SER)* | Ideal therapeutic goal (SER)*: | 1 year post-randomization (key secondary) |
- BASDAI ≤2 | ||
- Physician GA ≤2 | End of study | |
- Patient GA ≤2 | ||
Proportion of patients who are in remission (ASDAS-C) | ASDAS-C <1.3 | 1 and 2 years post-randomization, End of study |
Proportion of patients with disease relapse (SER)* | Disease relapse (SER)* | 1 and 2 years post-randomization, End of study |
Time to clinical relapse (SER)* | - BASDAI ≥4 | During study follow-up |
- Physician GA ≥4 AND one or more of 3: | ||
- Patient GA ≥ 4 | ||
- Nocturnal axial pain ≥ 4 | ||
- Increased CRP and/or ESR | ||
Proportion of patients with disease relapse (ASDAS-C) | ASDAS-C ≥2.1 | 1 and 2 years post-randomization, End of study |
Time to clinical relapse (ASDAS-C)* | During study follow-up | |
Proportion of patients with clinical relapse (BASDAI/Patient GA) | Clinical relapse | 1 and 2 years post-randomization, End of study |
Time to clinical relapse (BASDAI/Patient GA)* | - BASDAI increase by 20 % or by 2/10 points AND | During study follow-up |
- Patient GA increased by 20 % or 2/10 points | ||
Proportion of patients withdrawn due to requirement for changes in anti-TNFtreatment. | Unplanned change of the assigned anti-TNF regimen decided by the investigator due to lack of efficacy, safety issues or treatment-related reasons. | End of study |
NSAIDs use | Dougados criteria (42) | 1 and 2 years post-randomization, End of study |
Patient function (BASFI) | Change from baseline in the BASFI scores | 1 and 2 years post-randomization, End of study |
Ankylosing Spondylitis Quality of Life (ASQoL) | Change from baseline in the ASQoL (Spanish validated version of ASQoL (41)) | 1 and 2 years post-randomization, End of study |
Proportion of patients with any related severe adverse event | ≥1 severe adverse events with causality assessment at least possibly related to anti-TNF | |
Time to related severe adverse event | Number of days from randomization to first symptom of a severe adverse event with causality assessment at least possibly related to anti-TNF | |
Radiological progression | mSASSS |