Phase 2
Completed N=283
Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)
Source: ClinicalTrials.gov NCT01894516 ↗Enrolled (actual)
283
Serious AEs
3.0%
Results posted
Nov 2020
Primary outcomePrimary: Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 — 29.2; 66.7; 65.7; 72.5 percentage of participants — p=< 0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 |
29.2; 66.7; 65.7; 72.5 | < 0.0001 sig |
| SECONDARY Percentage of Participants Achieving an ACR20 Response at Week 24 |
56.9; 78.6; 66.7 | — |
| SECONDARY Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 |
1.4; 1.4; 10; 7.2; 4.2; 5.6 | — |
| SECONDARY Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 |
0; 0; 1.4; 1.4; 2.8; 1.4 | — |
| SECONDARY ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 |
6.79; 11.66; 12.84; 16.8; 10.79; 17.11 | — |
| SECONDARY 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 |
72; 57; 63; 49; 26; 40 | — |
| SECONDARY Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 |
0; 1.4; 0; 1.4; 0; 0 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 |
45.73; 43.77; 46.608; 44.139; -7.45; 9.596 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 |
42.168; 41.438; 44.052; 41.869; -6.867; -9.226 | — |
| SECONDARY Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 |
25.1; 25.1; 24.8; 24.8; 1.4; 7.2 | — |
| SECONDARY Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 |
31.1; 31.05; 30.946; 31.804; 2.1; 5.7 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01894516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.