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| ID | Type | Description | Link |
|---|---|---|---|
| 2007/2/0174 | Other Grant/Funding Number | Norwegian Foundation for Health and Rehabilitation |
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| Name | Class |
|---|---|
| Norwegian Foundation for Health and Rehabilitation | OTHER |
| University of Oslo | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cetrorelix |
|
| 2 | Placebo Comparator | NaCl solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetrorelix | Drug | 3-5 mg s.c. on days 1-5 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group | From baseline to day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in DAS28 (CRP/ESR) | From baseline to day 2/5 /10/15 | |
| Change in anti-CCP level | From baseline to day 2/5/10/15 | |
| Change in cytokine level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kåss | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deaprtment of Rheumatology, Betanien Hospital | Skien | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26460564 | Derived | Kass A, Hollan I, Fagerland MW, Gulseth HC, Torjesen PA, Forre OT. Rapid Anti-Inflammatory Effects of Gonadotropin-Releasing Hormone Antagonism in Rheumatoid Arthritis Patients with High Gonadotropin Levels in the AGRA Trial. PLoS One. 2015 Oct 13;10(10):e0139439. doi: 10.1371/journal.pone.0139439. eCollection 2015. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C062876 | cetrorelix |
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| Drug |
3-5 ml NaCl s.c. on days 1-5 |
|
| 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 |
| Adverse events | Number of patients with adverse events (and serious adverse events) up to day 15 in each group | Baseline up to day 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 | 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. | By day 2, 5, 10 and 15 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |