Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to compare the safety and efficacy of gonadotropin-releasing hormone (GnRH) antagonist therapy versus placebo in patients with moderate to severe rheumatoid arthritis.
Interventions
DRUGCetrorelix
3-5 mg s.c. on days 1-5
DRUGPlacebo
3-5 ml NaCl s.c. on days 1-5
Sponsors
Norwegian Foundation for Health and Rehabilitation
University of Oslo
Betanien Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult between 18 years and above * Moderate to severe disease activity * Negative pregnancy test for women of childbearing potential * Use of reliable method of contraception (non-hormonal) by sexually active female patients
Exclusion criteria
* Patients who are pregnant or breastfeeding * Patients taking biologic therapy or prednisolone \>7.5mg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group | From baseline to day 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in anti-CCP level | From baseline to day 2/5/10/15 | — |
| Change in cytokine level | From baseline to day 2/5/10/15 | — |
| Change in ACR core set measures | From baseline to day 2/5/10/15 | — |
| Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders | Baseilne to day 2/5/10/15 | — |
| Change in DAS28 (CRP/ESR) | From baseline to day 2/5 /10/15 | — |
| Proportion of patients with DAS28low disease activity/remission | Baseline to day 2/5/10/15 | — |
| Change in HAQ scores | From baseline to day 5/10/15 | — |
| Correlation between percent changes in hormones, disease activity and biomarkers | By day 2, 5, 10 and 15 | This endpoint is not directly related to clinical efficacy. Hormones include LH, FSH, oestradiol, testosterone,and cortisol. Biomarkers include immunologic markers, bone markers and cardiovascular markers. This secondary endpoint was sent to authorities during the study before unblinding. |
| Adverse events | Baseline up to day 15 | Number of patients with adverse events (and serious adverse events) up to day 15 in each group |
Countries
Norway
Outcome results
None listed