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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01894516




Registration number
NCT01894516
Ethics application status
Date submitted
4/07/2013
Date registered
10/07/2013
Date last updated
16/12/2020

Titles & IDs
Public title
Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)
Scientific title
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
Secondary ID [1] 0 0
GLPG0634-CL-204 (DARWIN2)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GLPG0634
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Participants received GLPG0634 matching placebo capsules, orally, once daily (QD) during Weeks 1 to 12 and GLPG0634 100 milligram (mg) QD during Weeks 13 to 24.

Experimental: GLPG0634 50 mg QD - 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.

Experimental: GLPG0634 100 mg QD - Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.

Experimental: GLPG0634 200 mg QD - Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.


Treatment: Drugs: GLPG0634
GLPG0634 capsules.

Treatment: Drugs: Placebo
Placebo capsules.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving an ACR20 Response at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
Timepoint [2] 0 0
Weeks 1, 2, 4, 8, 12, and 24
Secondary outcome [3] 0 0
Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24
Timepoint [3] 0 0
Weeks 1, 2, 4, 8, 12, and 24
Secondary outcome [4] 0 0
ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24
Timepoint [4] 0 0
Weeks 1, 2, 4, 8, 12, and 24
Secondary outcome [5] 0 0
Percentage of Participants With Disease Activity Score 28 Joints Corrected for CRP (DAS28 (CRP)) European League Against Rheumatism (EULAR) Response at Weeks 1, 2, 4, 8, 12, and 24
Timepoint [5] 0 0
Weeks 1, 2, 4, 8, 12, and 24
Secondary outcome [6] 0 0
Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24
Timepoint [6] 0 0
Weeks 4, 8, 12, and 24
Secondary outcome [7] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24
Timepoint [7] 0 0
Baseline and Weeks 1, 2, 4, 8, 12, and 24
Secondary outcome [8] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24
Timepoint [8] 0 0
Baseline and Weeks 1, 2, 4, 8, 12, and 24
Secondary outcome [9] 0 0
Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24
Timepoint [9] 0 0
Baseline and Weeks 4, 12, and 24
Secondary outcome [10] 0 0
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24
Timepoint [10] 0 0
Baseline and Weeks 4, 12, and 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/05/2015
Sample size
Target
Accrual to date
Final
287
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Woolloongabba
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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Texas
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Lanus
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Sofia
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Chile
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Bytom
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Bucuresti
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Galati
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Orenburg
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Elche
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Sabadell
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Ukraine
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Donetsk
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Kherson
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Kiev
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Ukraine
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Vinnytsya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Galapagos NV
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
- Participants suffering from active rheumatoid arthritis who had an inadequate response
to methotrexate were evaluated for improvement of disease activity (efficacy) when
taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg
once daily) or matching placebo for 24 weeks.

- During the course of the study, patients were also examined for any side effects that
could 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) were determined. Also, the
effects of different doses of GLPG0634 administration on participants' disability,
fatigue and quality of life were evaluated.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01894516
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Galapagos Study Director
Address 0 0
Galapagos NV
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries