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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 29 April 2020
Main ID:  EUCTR2015-001275-50-SE
Date of registration: 04/12/2015
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb International Corporation
Public title: Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis
Scientific title: A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive
Date of first enrolment: 09/12/2015
Target sample size: 1500
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001275-50
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Austria Brazil Canada Chile Colombia Czech Republic
Finland France Germany Hungary Israel Italy Japan Korea, Republic of
Mexico Netherlands Peru Poland Qatar Romania Russian Federation Saudi Arabia
Singapore South Africa Spain Sweden Taiwan United Arab Emirates United Kingdom
Contacts
Name: GCT-SU   
Address:  Parc de l'Alliance - Avenue de Finlande, 4 1420 Braine-l'Alleud Belgium
Telephone:
Email: clinical.trials@bms.com
Affiliation:  Bristol-Myers Squibb International Corporation
Name: GCT-SU   
Address:  Parc de l'Alliance - Avenue de Finlande, 4 1420 Braine-l'Alleud Belgium
Telephone:
Email: clinical.trials@bms.com
Affiliation:  Bristol-Myers Squibb International Corporation
Key inclusion & exclusion criteria
Inclusion criteria:
a) Subjects have early RA, defined as diagnosis made by the ACR/EULAR 2010 criteria for the classification of RA within the past 6 months
b) Subjects must meet at least one of the following criteria:
i) CRP > 0.3mg/dL (ULN)
ii) ESR = 28mm/hr
c) Subjects have at least 3 tender joints and at least 3 swollen joints using the 28 Joint Count Assessment at both screening and Day 1 (Appendix 11)
d) Subjects are positive for anti-citrullinated protein antibodies (ACPA)
e) Subjects have an SDAI > 11
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion criteria:
a) Subjects at risk for tuberculosis
b) Subjects with recent acute infection
c) Subjects with history of chronic or recurrent bacterial, viral or systemic fungal infections.
d) Subjects who have present or previous malignancies, except documented history of cured non-metastatic squamous or basal skin cell carcinoma, or cervical carcinoma in situ
e) Creatinine clearance < 40 mL/min (Cockroft-Gault formula)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Early Rheumatoid Arthritis
MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Product Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-

Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
Pharmaceutical Form: Capsule
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: The primary objective for this study is to compare the clinical efficacy of weekly abatacept in combination with MTX to MTX alone in achieving Remission, defined as SDAI = 3, at Week 24.
Primary end point(s): The primary efficacy endpoint is the proportion of subjects in SDAI Remission at Week 24.
Secondary Objective: 1) To compare the efficacy of weekly abatacept + MTX to MTX alone in achieving remission by DAS28-CRP Remission criteria at Week 24.
2) To compare the efficacy of weekly abatacept + MTX to MTX alone in achieving remission by SDAI remission criteria at Week 52.
3) To compare the efficacy of weekly abatacept + MTX to MTX alone in reducing joint damage by X-ray at Week 52.
4) To compare the efficacy of weekly abatacept + MTX to MTX alone in achieving remission by Boolean remission criteria at Week 52.
Timepoint(s) of evaluation of this end point: Week 24
Secondary Outcome(s)
Secondary end point(s): The secondary endpoints below will be assessed in the order below in a hierarchical fashion after the primary endpoint is met to preserve the type I error of the study at 5%
(1) Proportion of subjects in DA28-CRP Remission at Week 24
(2) Proportion of subjects in SDAI Remission at Week 52
(3) Mean change from baseline in TSS at Week 52
(4) Proportion of subjects in Boolean Remission at Week 52
Timepoint(s) of evaluation of this end point: (1) Week 24
(2) Week 52
(3) Week 52
(4) Week 52
Secondary ID(s)
2015-001275-50-CZ
IM101-550
Source(s) of Monetary Support
Bristol-Myers Squibb International Corporation
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 17/11/2015
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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