TriangleNCT01469013 · OUTCOME
Mean Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) Responses up to 12 Weeks (Part A)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, 12 weeks
What was measured
HAQ-DI was a participant-reported questionnaire that consisted of 24 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the week using response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 domains were required. Otherwise, HAQ-DI score was considered missing. The HAQ-DI score was the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3, 0 being without any difficulty and 3 being unable to do.
Analysis population: All participants who received any amount of study drug in Part A and had HAQ-DI evaluated at analysis time points. The last non-missing post-baseline value in Part A was used.
Groups in this outcome
1 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
2 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
4 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
8 mg Baricitinib (LY3009104)
Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
Placebo
Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
| Group | Source count |
|---|---|
| 1 mg Baricitinib (LY3009104) | 24 |
| 2 mg Baricitinib (LY3009104) | 24 |
| 4 mg Baricitinib (LY3009104) | 24 |
| 8 mg Baricitinib (LY3009104) | 24 |
| Placebo | 49 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1 mg Baricitinib (LY3009104) | -0.302 | 0.3336 | Not reported | Not reported | Not reported |
| 2 mg Baricitinib (LY3009104) | -0.396 | 0.4759 | Not reported | Not reported | Not reported |
| 4 mg Baricitinib (LY3009104) | -0.469 | 0.3463 | Not reported | Not reported | Not reported |
| 8 mg Baricitinib (LY3009104) | -0.422 | 0.3646 | Not reported | Not reported | Not reported |
| Placebo | -0.077 | 0.3552 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.3336
- value
- -0.302
- group Id
- OG001
- spread
- 0.4759
- value
- -0.396
- group Id
- OG002
- spread
- 0.3463
- value
- -0.469
- group Id
- OG003
- spread
- 0.3646
- value
- -0.422
- group Id
- OG004
- spread
- 0.3552
- value
- -0.077
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 24
- group Id
- OG003
- value
- 24
- group Id
- OG004
- value
- 49
- units
- Participants
- description
- HAQ-DI was a participant-reported questionnaire that consisted of 24 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the week using response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 domains were required. Otherwise, HAQ-DI score was considered missing. The HAQ-DI score was the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3, 0 being without any difficulty and 3 being unable to do.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
- id
- OG000
- title
- 1 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
- id
- OG001
- title
- 2 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
- id
- OG002
- title
- 4 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
- id
- OG003
- title
- 8 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
- id
- OG004
- title
- Placebo
- param Type
- MEAN
- population Description
- All participants who received any amount of study drug in Part A and had HAQ-DI evaluated at analysis time points. The last non-missing post-baseline value in Part A was used.
- reporting Status
- POSTED
- time Frame
- Baseline, 12 weeks
- title
- Mean Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) Responses up to 12 Weeks (Part A)
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice