Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

• Register: EUCTR
• Last refreshed on: 19 April 2022
• Main ID: EUCTR2015-001275-50-NL
• Date of registration: 10/12/2015
• 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: 08/06/2016
• 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
• Affiliation: Bristol-Myers Squibb International Corporation

• Name: GCT-SU
• 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Early Rheumatoid Arthritis
MedDRA version: 18.1 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-

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.

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

Primary end point(s): The primary efficacy endpoint is the proportion of subjects in SDAI Remission at 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

Ethics review

Status: Approved
Approval date: 08/06/2016
Contact:

Results

• Results available: Yes
• Date Posted: 04/04/2021
• Date Completed: 19/03/2020
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-001275-50/results