Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1) (DARWIN1)
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ClinicalTrials.gov Identifier: NCT01888874 |
Recruitment Status :
Completed
First Posted : June 28, 2013
Results First Posted : November 17, 2020
Last Update Posted : November 17, 2020
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Sponsor:
Galapagos NV
Information provided by (Responsible Party):
Galapagos NV
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Rheumatoid Arthritis |
Interventions |
Drug: GLPG0634 Drug: Placebo |
Enrollment | 599 |
Participant Flow
Recruitment Details | Participants were enrolled at study sites in Europe, South America, North America, Australia, and New Zealand. The first participant was screened on 17 July 2013. The last study visit occurred on 14 May 2015. |
Pre-assignment Details | A total of 1255 participants were screened of which 599 participants were randomized into the study and only 594 participants were treated. |
Arm/Group Title | Placebo | GLPG0634 50 mg QD | GLPG0634 100 mg QD | GLPG0634 200 mg QD | GLPG0634 25 mg BID | GLPG0634 50 mg BID | GLPG0634 100 mg BID |
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Participants received GLPG0634 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 milligram (mg) once daily (QD) or 50 mg BID during Weeks 13 to 24. | Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24. | Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24. | Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24. | Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24. | Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24. | Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24. |
Period Title: Period 1 (Baseline up to Week 12) | |||||||
Started | 86 | 82 | 85 | 86 | 86 | 85 | 84 |
Completed | 83 | 76 | 78 | 80 | 77 | 80 | 83 |
Not Completed | 3 | 6 | 7 | 6 | 9 | 5 | 1 |
Reason Not Completed | |||||||
Withdrawal by Subject | 2 | 2 | 3 | 4 | 3 | 0 | 0 |
Other | 1 | 0 | 1 | 1 | 3 | 3 | 0 |
Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Adverse Event | 0 | 2 | 3 | 1 | 2 | 1 | 0 |
Adverse event and treatment failure | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Non-compliance with the study procedures | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
Period Title: Period 2 (Week 13 to Week 24) | |||||||
Started | 53 [1] | 57 [2] | 112 [3] | 80 | 60 [4] | 112 [5] | 83 |
Completed | 50 | 55 | 104 | 78 | 57 | 109 | 80 |
Not Completed | 3 | 2 | 8 | 2 | 3 | 3 | 3 |
Reason Not Completed | |||||||
Withdrawal by Subject | 1 | 1 | 2 | 0 | 1 | 0 | 0 |
Adverse event and treatment failure | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Non compliance with study medication | 0 | 0 | 2 | 0 | 0 | 1 | 0 |
Treatment failure | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Adverse Event | 2 | 0 | 3 | 2 | 1 | 1 | 3 |
Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
[1]
Nonresponders from Placebo group moved to 100 mg QD(15 participants) and 50 mg BID(15 participants).
[2]
Nonresponders from 50 mg QD group moved to 100 mg QD group (19 participants).
[3]
Nonresponders from Placebo(15 participants) and 50 mg QD (19 participants) moved to 100 mg QD group.
[4]
Nonresponders from 25 mg BID group moved to 50 mg BID group (17 participants).
[5]
Nonresponders from Placebo(15 participants) and 25 mg BID(17 participants) moved to 50 mg BID group.
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Baseline Characteristics
Arm/Group Title | Placebo | GLPG0634 50 mg QD | GLPG0634 100 mg QD | GLPG0634 200 mg QD | GLPG0634 25 mg BID | GLPG0634 50 mg BID | GLPG0634 100 mg BID | Total | |
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Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24. | Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24. | Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24. | Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24. | Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24. | Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24. | Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24. | Total of all reporting groups | |
Overall Number of Baseline Participants | 86 | 82 | 85 | 86 | 86 | 85 | 84 | 594 | |
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Safety population included all participants who were randomized and received at least one dose of study medication.
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 86 participants | 82 participants | 85 participants | 86 participants | 86 participants | 85 participants | 84 participants | 594 participants | |
52
(18 to 84)
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52.8
(20 to 77)
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52.3
(20 to 79)
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54.8
(19 to 75)
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52.4
(24 to 79)
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55.4
(21 to 78)
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53.9
(22 to 76)
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53.4
(18 to 84)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 86 participants | 82 participants | 85 participants | 86 participants | 86 participants | 85 participants | 84 participants | 594 participants | |
Female |
70 81.4%
|
69 84.1%
|
65 76.5%
|
74 86.0%
|
68 79.1%
|
65 76.5%
|
70 83.3%
|
481 81.0%
|
|
Male |
16 18.6%
|
13 15.9%
|
20 23.5%
|
12 14.0%
|
18 20.9%
|
20 23.5%
|
14 16.7%
|
113 19.0%
|
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 86 participants | 82 participants | 85 participants | 86 participants | 86 participants | 85 participants | 84 participants | 594 participants | |
Hispanic or Latino |
37 43.0%
|
37 45.1%
|
33 38.8%
|
33 38.4%
|
37 43.0%
|
30 35.3%
|
38 45.2%
|
245 41.2%
|
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Not Hispanic or Latino |
49 57.0%
|
45 54.9%
|
52 61.2%
|
53 61.6%
|
49 57.0%
|
55 64.7%
|
46 54.8%
|
349 58.8%
|
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Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||
Number Analyzed | 86 participants | 82 participants | 85 participants | 86 participants | 86 participants | 85 participants | 84 participants | 594 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
1 1.2%
|
0 0.0%
|
0 0.0%
|
1 1.2%
|
0 0.0%
|
2 0.3%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
1 1.2%
|
0 0.0%
|
0 0.0%
|
1 1.2%
|
0 0.0%
|
0 0.0%
|
1 1.2%
|
3 0.5%
|
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White |
59 68.6%
|
61 74.4%
|
62 72.9%
|
67 77.9%
|
63 73.3%
|
65 76.5%
|
66 78.6%
|
443 74.6%
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More than one race |
26 30.2%
|
21 25.6%
|
22 25.9%
|
18 20.9%
|
23 26.7%
|
19 22.4%
|
17 20.2%
|
146 24.6%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Rheumatoid Arthritis (RA) duration
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 86 participants | 82 participants | 85 participants | 86 participants | 86 participants | 85 participants | 84 participants | 594 participants | |
8.21
(0.5 to 36.5)
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7.21
(0.6 to 21.3)
|
7.67
(0.6 to 32.6)
|
8.51
(0.5 to 34.5)
|
8.88
(0.5 to 30.1)
|
7.79
(0.5 to 28.8)
|
9.74
(0.5 to 43.2)
|
8.29
(0.5 to 43.2)
|
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C-reactive protein (CRP) at Baseline
Mean (Full Range) Unit of measure: Milligram per liter (mg/L) |
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Number Analyzed | 86 participants | 82 participants | 85 participants | 86 participants | 86 participants | 85 participants | 84 participants | 594 participants | |
16.25
(1 to 84.5)
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27.71
(1 to 158.7)
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24.54
(1 to 140.7)
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27.1
(1 to 140.9)
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26.01
(1.2 to 157.3)
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24.6
(1 to 113.4)
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26.86
(1 to 129.4)
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24.70
(1 to 158.7)
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Corrected tender joint count based on 68 joints (TJC68) at Baseline
[1] Mean (Full Range) Unit of measure: Joint count |
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Number Analyzed | 86 participants | 82 participants | 85 participants | 86 participants | 86 participants | 85 participants | 84 participants | 594 participants | |
24.984
(8 to 60)
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24.907
(8 to 64)
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25.319
(8 to 68)
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28.843
(8 to 68)
|
25.427
(8 to 64)
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27.158
(8 to 66)
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25.946
(7 to 61)
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26.091
(7 to 68)
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[1]
Measure Description: 68 joints were assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
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Corrected swollen joint count based on 66 joints (SJC66) at Baseline
[1] Mean (Full Range) Unit of measure: Joint count |
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Number Analyzed | 86 participants | 82 participants | 85 participants | 86 participants | 86 participants | 85 participants | 84 participants | 594 participants | |
16.13
(6 to 48)
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17.023
(6 to 66)
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16.31
(6 to 54)
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17.355
(6 to 58)
|
15.663
(6 to 40)
|
17.534
(6 to 62)
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16.356
(6 to 48)
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16.622
(6 to 66)
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[1]
Measure Description: 66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
Results Point of Contact
Name/Title: | Clinical Trial Information Desk |
Organization: | Galapagos N.V. |
Phone: | +32 (0)15 342 900 |
EMail: | rd@glpg.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Galapagos NV |
ClinicalTrials.gov Identifier: | NCT01888874 |
Other Study ID Numbers: |
GLPG0634-CL-203 (DARWIN1) 2012-003635-31 ( EudraCT Number ) |
First Submitted: | June 26, 2013 |
First Posted: | June 28, 2013 |
Results First Submitted: | October 26, 2020 |
Results First Posted: | November 17, 2020 |
Last Update Posted: | November 17, 2020 |