Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Patients (DARWIN1)



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2013
End Date:June 2015

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Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

- 595 patients suffering from active rheumatoid arthritis despite continued treatment
with methotrexate will be evaluated for improvement of disease activity (efficacy) when
taking GLPG0634 (3 different doses - 50mg, 100mg and 200mg daily -, each evaluated as
QD and BID regimen) or matching placebo for 24 weeks.

- During the course of the study, patients will also be examined for any side effects
that may occur (safety and tolerability), and the amount of GLPG0634 present in the
blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism
of action-related parameters in the blood (Pharmacodynamics) will be determined. Also,
the effects of different doses and dose regiments of GLPG0634 administration on
subjects' disability, fatigue, and quality of life will be evaluated.

- Treatment duration will be 24 weeks in total.

- However, at Week 12, subjects on placebo who have not achieved a 20% improvement in
swollen joint count(SJC66) and tender joint count (TJC68) will be re-randomized
(automatically via interactive voice/web response [IXRS]) to treatment to receive
GLPG0634 100 mg q.d. or 50 mg b.i.d. doses in a blinded fashion, subjects on 50 mg q.d.
who have not achieved a 20% improvement in SJC66 and TJC68 will be assigned to 100 mg
q.d. and subjects on 25 mg b.i.d. who have not achieved a 20% improvement in SJC66 and
TJC68 will be assigned to 50 mg b.i.d. All will continue the study until Week 24.

- Subjects in the other groups will maintain their randomized treatment until Week 24.

Inclusion Criteria:

- male or female subjects who are ≥18 years of age, on the day of signing informed
consent,

- have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR
criteria of RA and ACR functional class I-III,

- have ≥6 swollen joints (from a 66 joint count) and

≥8 tender joints (from a 68 joint count) at Screening and at Baseline,

- Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range
(ULN),

- have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of
MTX for at least 4 weeks prior to Screening and willing to continue on their current
regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are
allowed when there is documented evidence of intolerance or safety issues at higher
doses.

Exclusion Criteria:

- current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than
MTX,

- current or previous RA treatment with a biologic DMARD, with the exception of
biologic DMARDs administered in a single clinical study setting more than 6 months
prior to Screening (12 months for rituximab or other B cell depleting agents), where
the biologic DMARD was effective, and if discontinued, this should not be due to lack
of efficacy,

- previous treatment at any time with a cytotoxic agent, other than MTX, before
Screening.
We found this trial at
29
sites
Oklahoma City, Oklahoma 73103
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Austin, Texas 78705
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Austin, TX
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Boca Raton, Florida
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Boca Raton, FL
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Buenos Aires,
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Clarksburg, West Virginia 26301
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Clarksburg, WV
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Dallas, TX
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Frederick, Maryland 21702
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Frederick, MD
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Gainesville, Georgia
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Gainesville, GA
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Gilbert, AZ
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Greenville, North Carolina 27834
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Hagerstown, Maryland 21740
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Hagerstown, MD
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Hemet, CA
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Houston, Texas 77098
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Houston, TX
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Huntsville, AL
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La Jolla, CA
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Lansing, Michigan 48910
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Lansing, MI
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Meridian, Idaho
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Meridian, ID
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Ormond Beach, Florida 32174
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Palm Desert, California 92260
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Palm Desert, CA
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Phoenix, AZ
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Rochester, Minnesota 55905
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Rochester, MN
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Seattle, Washington 98104
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Seattle, WA
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Springfield, Illinois 62704
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Springfield, IL
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Venice, FL
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Victoria, TX
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Victorville, California
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West Hills, California 91307
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West Hills, CA
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Wichita, KS
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