Short-term treatment with a gonadotropin-releasing hormone antagonist, cetrorelix, in rheumatoid arthritis (AGRA): a randomized, double-blind, placebo-controlled study.

Kåss AS, Førre OT, Fagerland MW, Gulseth HC, Torjesen PA, Hollan I

Scandinavian journal of rheumatology1 Nov 2013Cited by 7 (Europe PMC)

PMID24182325PMCIDPMC3913106DOI10.3109/03009742.2013.825007PepBankPUB-24182325

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Summary

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Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In RA patients, cetrorelix did not significantly reduce DAS28-CRP versus placebo by day 5 (0.82 versus 0.57 reduction, p = 0.091).
In plain wordsIn RA patients, cetrorelix did not significantly reduce disease activity compared with placebo by day 5.
Peptide
Cetrorelix
Outcome
No significant changeDAS28-CRP change by day 5
Study
n = 99
Comparator
Placebo
Analysis
Primary
Outcome group
Bone and joint · Immune and inflammation
Studied dose
5 mg/day on days 1 and 2; 3 mg/day on days 3-5 · subcutaneousAs given in this study (human).
Measurements
DAS28-CRP reduction
0.82 points
cetrorelix
DAS28-CRP reduction
0.57 points
placebo
Source sentences
Summary
By day 5, DAS28-CRP was non-significantly reduced by 0.82 in the cetrorelix group compared to a 0.57 reduction in the placebo group (p = 0.091),
2 context sentences(design, population, supporting numbers)
Summary · context
The primary end-point was the change in the 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) by day 5, when the greatest GnRH suppression was anticipated.
Summary · context
In this proof-of-concept, randomized, double-blind study involving 99 patients with active, long-standing RA, 48 patients received subcutaneous cetrorelix (5 mg/day on days 1 and 2; 3 mg/day on days 3-5) and 51 received placebo.
Report a problemFND-2418232501
02HumanRandomized controlled trialEfficacy outcome
In RA patients, cetrorelix reduced TNF-α versus placebo by day 5 (0.55 log pg/mL, 95% CI 0.08-1.01, p = 0.023).
In plain wordsIn RA patients, cetrorelix reduced TNF-α compared with placebo by day 5.
Peptide
Cetrorelix
Outcome
DecreaseTNF-α reduction by day 5
Study
n = 99
Comparator
Placebo
Analysis
Secondary
Outcome group
Inflammation markers · Immune and inflammation
Studied dose
5 mg/day on days 1 and 2; 3 mg/day on days 3-5 · subcutaneousAs given in this study (human).
Measurements
TNF-α reduction
0.55 log pg/mL
versus placebo
95% CI
0.08 to 1.01 log pg/mL
TNF-α reduction
Source sentences
Summary
TNF-α (log pg/mL) was significantly reduced in the cetrorelix group compared with the placebo group [0.55, 95% confidence interval (CI) 0.08-1.01, p = 0.023]
2 context sentences(design, population, supporting numbers)
Summary · context
Secondary end-points included the change in tumour necrosis factor (TNF)-α, and achievement of American College of Rheumatology (ACR) responses and DAS28-CRP < 2.6 by day 5.
Summary · context
In this proof-of-concept, randomized, double-blind study involving 99 patients with active, long-standing RA, 48 patients received subcutaneous cetrorelix (5 mg/day on days 1 and 2; 3 mg/day on days 3-5) and 51 received placebo.
Report a problemFND-2418232502
03HumanRandomized controlled trialEfficacy outcome
In RA patients, cetrorelix increased ACR20 responses versus placebo by day 5 (40% versus 18%, p = 0.015).
In plain wordsIn RA patients, cetrorelix increased ACR20 responses compared with placebo by day 5.
Peptide
Cetrorelix
Outcome
IncreaseACR20 response by day 5
Study
n = 99
Comparator
Placebo
Analysis
Secondary
Outcome group
Bone and joint · Immune and inflammation
Studied dose
5 mg/day on days 1 and 2; 3 mg/day on days 3-5 · subcutaneousAs given in this study (human).
Measurements
ACR20 response
40%
cetrorelix
ACR20 response
18%
placebo
Source sentences
Summary
and more patients on cetrorelix achieved ACR20 responses (40% vs. 18%, p = 0.015)
2 context sentences(design, population, supporting numbers)
Summary · context
Secondary end-points included the change in tumour necrosis factor (TNF)-α, and achievement of American College of Rheumatology (ACR) responses and DAS28-CRP < 2.6 by day 5.
Summary · context
In this proof-of-concept, randomized, double-blind study involving 99 patients with active, long-standing RA, 48 patients received subcutaneous cetrorelix (5 mg/day on days 1 and 2; 3 mg/day on days 3-5) and 51 received placebo.
Report a problemFND-2418232503
04HumanRandomized controlled trialEfficacy outcome
In RA patients, cetrorelix increased DAS28-CRP < 2.6 attainment versus placebo by day 5 (13% versus 0%, p = 0.009).
In plain wordsIn RA patients, more people on cetrorelix than on placebo reached a DAS28-CRP below 2.6 by day 5.
Peptide
Cetrorelix
Outcome
IncreaseDAS28-CRP < 2.6 by day 5
Study
n = 99
Comparator
Placebo
Analysis
Secondary
Outcome group
Bone and joint · Immune and inflammation
Studied dose
5 mg/day on days 1 and 2; 3 mg/day on days 3-5 · subcutaneousAs given in this study (human).
Measurements
DAS28-CRP < 2.6
13%
cetrorelix
DAS28-CRP < 2.6
0%
placebo
Source sentences
Summary
and more patients on cetrorelix achieved ACR20 responses (40% vs. 18%, p = 0.015) and DAS28-CRP < 2.6 (13% vs. 0%, p = 0.009).
2 context sentences(design, population, supporting numbers)
Summary · context
Secondary end-points included the change in tumour necrosis factor (TNF)-α, and achievement of American College of Rheumatology (ACR) responses and DAS28-CRP < 2.6 by day 5.
Summary · context
In this proof-of-concept, randomized, double-blind study involving 99 patients with active, long-standing RA, 48 patients received subcutaneous cetrorelix (5 mg/day on days 1 and 2; 3 mg/day on days 3-5) and 51 received placebo.
Report a problemFND-2418232504
05HumanRandomized controlled trialSafety outcome
In RA patients, adverse event rates were similar with cetrorelix and placebo.
In plain wordsIn RA patients, adverse event rates were similar with cetrorelix and placebo.
Peptide
Cetrorelix
Outcome
No significant changeAdverse event rate
Study
n = 99
Comparator
Placebo
Outcome group
Adverse events · Immune and inflammation
Studied dose
5 mg/day on days 1 and 2; 3 mg/day on days 3-5 · subcutaneousAs given in this study (human).
Source sentences
Summary
Rates of adverse events were similar in both groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In this proof-of-concept, randomized, double-blind study involving 99 patients with active, long-standing RA, 48 patients received subcutaneous cetrorelix (5 mg/day on days 1 and 2; 3 mg/day on days 3-5) and 51 received placebo.
Report a problemFND-2418232506
06HumanNon-randomized trialEfficacy outcome
In RA patients, inflammatory markers increased towards baseline after cetrorelix withdrawal.
In plain wordsIn RA patients, inflammatory markers increased towards baseline after cetrorelix withdrawal.
Peptide
Cetrorelix
Outcome
IncreaseInflammatory markers after withdrawal
Study
n = 48
Comparator
Levels before withdrawal
Outcome group
Inflammation markers · Immune and inflammation
Studied dose
5 mg/day on days 1 and 2; 3 mg/day on days 3-5 · subcutaneousAs given in this study (human).
Source sentences
Summary
Inflammatory markers increased towards baseline levels after withdrawal of treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
In this proof-of-concept, randomized, double-blind study involving 99 patients with active, long-standing RA, 48 patients received subcutaneous cetrorelix (5 mg/day on days 1 and 2; 3 mg/day on days 3-5) and 51 received placebo.
Report a problemFND-2418232505

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PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

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