REMission INDuction in Very Early Rheumatoid Arthritis
Sleutelwoorden
Abstract
Omschrijving
Secondary endpoints:
Phase I (Remission induction):
- The proportion of patients on MTX/HCQ/GC in remission, defined as DAS28<2.6, at week 12 or week 24 after start of treatment.
- The proportion of patients on MTX/GOL in sustained remission, defined as DAS28<2.6 with max 4 swollen joints of the 44SJC at 2 consecutive visits 3 months apart, at week 24 after start of GOL treatment.
- Predictors of remission upon treatment with MTX, HCQ and a single injection of i.m. GC (e.g. smoking status, BMI, alcohol use, sex, disease duration, DAS28, Rheumatoid Factor (RF) -status, Anti-citrullinated protein antibody (ACPA) -status, presence of erosions)
- Predictors of remission upon treatment with MTX and GOL (e.g. smoking status, BMI, alcohol use, sex, disease duration, DAS28, RF-status, ACPA-status, presence of erosions)
Phase II (Tapering):
- The proportion of patients in sustained remission, defined as DAS28<2.6 with max 4 swollen joints of the 44SJC at 2 consecutive visits 3 months apart, at week 48 after start of tapering MTX first, then GOL or GOL first, then MTX.
- The proportion of patients in drug-free sustained remission, defined as DAS28<2.6 with max 4 swollen joints of the 44SJC at 2 consecutive visits 3 months apart while off anti-rheumatic treatment, at week 48 after start of tapering
- Mean disease activity, using the disease activity score assessing 28 joints (DAS28), at week 24 and week 48 after start of tapering
- Mean functional ability, using the Dutch consensus health assessment questionnaire (HAQ), at week 24 and week 48 after start of tapering
- Mean quality of life, using the visual analogue scale (VAS) of the EuroQol 5 dimensions (EQ5D) questionnaire, at week 24 and week 48 after start of tapering
- Mean anxiety and depression (using the Hospital Anxiety and Depression Scale (HADS)), at week 24 and week 48 after start of tapering
- Mean fatigue (using the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F)), at week 24 and week 48 after start of tapering
- The proportion of serious adverse events (SAEs) in the two tapering strategies after 24 and after 48 weeks.
- The time until remission (DAS28<2.6) after retreatment with the last effective dose upon flare while tapering MTX/GOL.
Phase III (Follow-up):
- The proportion of patients in drug-free sustained remission, defined as DAS28<2.6 with max 4 swollen joints of the 44SJC at 2 consecutive visits 3 months apart while off anti-rheumatic treatment, at week 48 after discontinuation of both MTX and GOL
- The time until remission, defined as DAS28<2.6, after retreatment in clinical care upon flare
- The proportion of serious adverse events (SAEs) in the two tapering strategies at week 24 and week 48.
Phase II and III:
- Cost per extra patient in remission up to week 96 after start of tapering (end of phase III)
- Cost per Quality Adjusted life Year (QALY) gained up to week 96 after start of tapering (end of phase III)
Overall:
- The sensitivity and predictive value of the patient reported Routine Assessment of Patient Index Data 3 (RAPID3) to detect remission and flare
Datums
| Laatst geverifieerd: | 03/31/2019 |
| Eerste ingediend: | 10/09/2016 |
| Geschatte inschrijving ingediend: | 10/12/2016 |
| Eerst geplaatst: | 10/16/2016 |
| Laatste update ingediend: | 04/24/2019 |
| Laatste update geplaatst: | 04/28/2019 |
| Werkelijke startdatum van het onderzoek: | 04/20/2017 |
| Geschatte primaire voltooiingsdatum: | 01/08/2019 |
| Geschatte voltooiingsdatum van het onderzoek: | 01/08/2019 |
Conditie of ziekte
Interventie / behandeling
Other: Taper
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: Taper methotrexate, then golimumab Taper methotrexate 25>0mg/wk during 24 weeks, then, if still in sustained remission, taper golimumab 50>0mg/month during 24 weeks. | |
| Active Comparator: Taper golimumab, then methotrexate Taper golimumab 50>0mg/month during 24 weeks, then, if still in sustained remission, taper methotrexate 25>0mg/wk during 24 weeks. |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | Inclusion Criteria: - Fulfilling 2010 ACR/EULAR criteria for RA. - Patient reported symptom duration < 12 months - Naïve for DMARD and biological treatment - Naïve for previous use of glucocorticoids for RA - DAS28 ≥3.2 Exclusion Criteria: - Being pregnant or being a nursing women or a women of child bearing potential without (adequate) use of contraception - Having any other inflammatory rheumatic disease than RA, except for secondary Sjögren's syndrome |
Resultaat
Primaire uitkomstmaten
1. proportion of patients in sustained remission [At week 24 after start of tapering]
