Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 |
This accounts for participants achieving 50% improvement in BASDAI. |
24 Weeks after initiation of Humira therapy |
|
Secondary |
Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24 |
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. |
24 Weeks after initiation of Humira therapy |
|
Secondary |
Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24 |
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. |
24 Weeks after initiation of Humira therapy |
|
Secondary |
Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
This accounts for participants achieving 50% improvement in BASDAI. |
Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) |
|
Secondary |
Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) |
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. |
Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) |
|
Secondary |
Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) |
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. |
Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) |
|
Secondary |
Percentages of participants whose disease activity states are inactive per ASDAS score |
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. |
At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) |
|
Secondary |
Percentages of participants whose disease activity states are moderate per ASDAS score |
The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. |
At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) |
|
Secondary |
Changes of the frequency of overall extra-articular manifestations (EAM) of interest |
The change of the frequency of overall extra-articular manifestations (EAM) will be assessed. |
At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) |
|
Secondary |
Changes of the respective frequency of each EAM |
The changes of the respective frequency of each EAM will be assessed. |
At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) |
|
Secondary |
Changes in the percentage of participants who have enthesitis of the plantar fascia or Achilles tendon |
The change in the percentage of participants who have enthesitis of the plantar fascia or Achilles tendon will be assessed. |
At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) |
|
Secondary |
Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) |
The change in MASES score will be assessed. |
At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) |
|
Secondary |
Change in Tender Joint Counts (TJC) |
The change of TJC (0-46), in participants who had peripheral arthritis (=1 swollen joint) at baseline will be assessed. |
At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) |
|
Secondary |
Change in Swollen Joint Counts (SJC) |
The change of SJC (0-44), in participants who had peripheral arthritis (=1 swollen joint) at baseline will be assessed. |
At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks) |
|