Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Patients (DARWIN2)
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: | July 2015 |
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone
- 280 patients suffering from active rheumatoid arthritis who have an inadequate response
to methotrexate will be evaluated for improvement of disease activity (efficacy) when
taking GLPG0634 as monotherapy (3 different doses - 50mg, 100mg and 200mg once daily)
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 of GLPG0634 administration on subjects' disability,
fatigue and quality of life will be evaluated.
to methotrexate will be evaluated for improvement of disease activity (efficacy) when
taking GLPG0634 as monotherapy (3 different doses - 50mg, 100mg and 200mg once daily)
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 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, all subjects on placebo and the subjects on the 50 mg dose who
have not achieved 20% improvement in swollen joint count (SJC66) and tender joint count
(TJC68) will be assigned (automatically via interactive web response system (IWRS)) to
100 mg q.d. in a blinded fashion and will continue treatment until Week 24.
- Subjects in the other groups will maintain their randomized treatment until Week 24.
- However, at Week 12, all subjects on placebo and the subjects on the 50 mg dose who
have not achieved 20% improvement in swollen joint count (SJC66) and tender joint count
(TJC68) will be assigned (automatically via interactive web response system (IWRS)) to
100 mg q.d. in a blinded fashion and will continue treatment 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 shown an inadequate response in terms of either lack of efficacy or toxicity to
MTX,
- have agreed to be washed out from MTX for a period of at least 4 weeks before or
during the Screening period.
Exclusion Criteria:
- current therapy with any non-biological disease modifying anti-rheumatic drug
(DMARD), with the exception of antimalarials, which must be at a stable dose for at
least 12 weeks prior to Screening,
- current or previous RA treatment with a biologic DMARD, with the exception of
biologic DMARDs: administered in a single clinical study setting, and; more than 6
months prior to Screening (12 months for rituximab or other B cell depleting agents),
and; 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
22
sites
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