Rheumatoid ArthritisPhase 2AGRANCT00667758
Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis
A Phase 2 study testing Cetrorelix in people with Rheumatoid Arthritis, run by Betanien Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Cetrorelix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteNorway
- Study dates
- May 2008to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are pregnant or breastfeeding
- Patients taking biologic therapy or prednisolone >7.5mg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Cetrorelix, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetrorelixDrug
3-5 mg s.c. on days 1-5
PlaceboDrug
3-5 ml NaCl s.c. on days 1-5
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cetrorelix Receives: Drug: Cetrorelix |
| 2 | Placebo comparator | NaCl solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group
Measured: From baseline to day 5
Secondary outcomes (9)
Change in DAS28 (CRP/ESR)
Measured: From baseline to day 2/5 /10/15
Change in anti-CCP level
Measured: From baseline to day 2/5/10/15
Change in cytokine level
Measured: From baseline to day 2/5/10/15
Change in ACR core set measures
Measured: From baseline to day 2/5/10/15
Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders
Measured: 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
Measured: Baseline up to day 15
Proportion of patients with DAS28low disease activity/remission
Measured: Baseline to day 2/5/10/15
Change in HAQ scores
Measured: 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.
Measured: By day 2, 5, 10 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Betanien Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation, University of Oslo
- Responsible party
- Principal investigator, Anita Kass, Betanien Hospital
- Investigators
- Kåss, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667758
- Sponsor's protocol ID
- R1/05
- Other IDs
- 2007/2/0174
- Acronym
- AGRA
- Status last verified
- Aug 2012
- First submitted
- 24 Apr 2008
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26460564
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00667758
- Acronym / sponsor ID
- AGRA / R1/05
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Betanien HospitalUniversity, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation, University of Oslo
- Study start
- May 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CetrorelixCetrorelix |
| 2 | Placebo comparator | Drug: PlaceboNaCl solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are pregnant or breastfeeding
- Patients taking biologic therapy or prednisolone >7.5mg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetrorelix3-5 mg s.c. on days 1-5 | Drug | 1 |
| Placebo3-5 ml NaCl s.c. on days 1-5 | Drug | 2 |
Primary outcome
Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group
Time frame: From baseline to day 5
9 secondary outcomes
Change in DAS28 (CRP/ESR)
Time frame: From baseline to day 2/5 /10/15
Change in anti-CCP level
Time frame: From baseline to day 2/5/10/15
Change in cytokine level
Time frame: From baseline to day 2/5/10/15
Change in ACR core set measures
Time frame: From baseline to day 2/5/10/15
Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders
Time frame: Baseilne to day 2/5/10/15
Adverse events
Time frame: Baseline up to day 15
Proportion of patients with DAS28low disease activity/remission
Time frame: Baseline to day 2/5/10/15
Change in HAQ scores
Time frame: From baseline to day 5/10/15
Correlation between percent changes in hormones, disease activity and biomarkers
Time frame: By day 2, 5, 10 and 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Derived from this study: PubMed 26460564Kass 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kåss principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetrorelix in people with Rheumatoid Arthritis, run by Betanien Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group (time frame: From baseline to day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00667758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2012.