Trial record 1 of 4 for:
GSK3196165 AND MTX
Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02799472 |
|
Recruitment Status :
Completed
First Posted : June 14, 2016
Results First Posted : November 16, 2018
Last Update Posted : July 9, 2019
|
Sponsor:
GlaxoSmithKline
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Arthritis, Rheumatoid |
| Interventions |
Drug: GSK3196165 Drug: Placebo Drug: MTX Drug: Folic (or folinic) acid |
| Enrollment | 39 |
Participant Flow
| Recruitment Details | A total of 39 participants with active early/established Rheumatoid arthritis were randomized across 9 centers in 3 countries from 15 June 2016 to 30 October 2017. |
| Pre-assignment Details | Out of the 88 participants screened for this study, 49 participants were screen failures and 39 participants were randomized and received treatment in the study. |
| Arm/Group Title | Placebo | GSK3196165 180 mg |
|---|---|---|
 Arm/Group Description |
Eligible participants received matching placebo subcutaneously (SC) into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received methotrexate (MTX) 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period. | Eligible participants received GSK3196165 180 milligrams (mg) SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period. |
| Period Title: Overall Study | ||
| Started | 11 | 28 |
| Completed | 7 | 23 |
| Not Completed | 4 | 5 |
| Reason Not Completed | ||
| Withdrawal by Subject | 2 | 4 |
| Lack of Efficacy | 2 | 0 |
| Lost to Follow-up | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Placebo | GSK3196165 180 mg | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period. | Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 11 | 28 | 39 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 11 participants | 28 participants | 39 participants | |
| 50.3 (11.57) | 59.1 (9.47) | 56.6 (10.73) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 11 participants | 28 participants | 39 participants | |
| Female |
10 90.9%
|
24 85.7%
|
34 87.2%
|
|
| Male |
1 9.1%
|
4 14.3%
|
5 12.8%
|
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 11 participants | 28 participants | 39 participants |
| Black or African American |
2 18.2%
|
4 14.3%
|
6 15.4%
|
|
| White |
9 81.8%
|
24 85.7%
|
33 84.6%
|
|