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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: 15 September 2020
Main ID:  EUCTR2014-000555-93-ES
Date of registration: 10/10/2017
Prospective Registration: Yes
Primary sponsor: Universitätsklinikum Erlangen
Public title: Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia
Scientific title: Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia
Date of first enrolment: 18/12/2017
Target sample size: 98
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000555-93
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: no
Placebo: yes
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
Brazil Czech Republic Germany Spain
Contacts
Name: Lead Clinical Physician   
Address:  Ulmenweg 18 91054 Erlangen Germany
Telephone: 0049913185 32093
Email:
Affiliation:  Universitätsklinikum Erlangen - Medizinische Klinik 3
Name: Lead Clinical Physician   
Address:  Ulmenweg 18 91054 Erlangen Germany
Telephone: 0049913185 32093
Email:
Affiliation:  Universitätsklinikum Erlangen - Medizinische Klinik 3
Key inclusion & exclusion criteria
Inclusion criteria:
- Females and males aged =18 years at time of consent
- ACPA (with or without RF)
- Joint pain (hand, feet, knee, shoulder or elbow) present for at least 6 weeks prior to inclusion or in past history
- Presence of synovitis (synovialitis or tenosynovitis) or osteitis in MRI of the dominant hand at baseline
-Women of childbearing potential or men capable of fathering children must be using effective
contraception during treatment with abatacept and up to 14 weeks after the last dose of abatacept treatment.
- Must understand and voluntarily sign an informed consent form including written consent for data protection
-Must be able to adhere to the study visit schedule and other protocol requirements
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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion criteria:
-Presence of arthritis in hand, feet, knee, shoulder or elbow joints defined as swelling
-Current treatment with glucocorticoids conventional or biologic DMARDs
-Previous treatment with abatacept
-Investigational study drug within 4 weeks (or 5 half lives, whichever is longer) prior to randomisation
-Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret
data from the study
-Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, SpA, Behcet disease, vasculitis or autoimmune hepatitis.
-Any malignancy in the last 5 years
-Chronic infection such as latent TB, (TB not adequately treated according to guidelines), or hepatitis B or C infection
-Immunocompromised or HIV-positive patients
-Uncontrolled severe concomitant disease
-Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and §
41 Abs. 2 and Abs. 3 AMG).
-Pregnant or lactating females
-Patients who possibly are dependent on the Principal Investigator or Investigator (e.g. family members)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Diagnosis of Initial phase of Rheumatoid Arthritis with arthralgia for at least 6 weeks without signs of joints swelling but with presence of ACPA antibodies and signs of joints swelling detected in MRI.
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Intervention(s)

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

Primary Outcome(s)
Main Objective: To explore whether subclinical MRI inflammatory lesions are reduced in a higher proportion of ACPA positive arthralgia patients treated with abatacept s.c. 125mg/week than placebo after 6 months.
Primary end point(s): Proportion of patients with an improvement of acute inflammation
characterised as improvement of s ynovitis (synovialitis or tenosynovitis) or osteitis in the MRI of the dominant hand after 6 months of treatment with abatacept or placebo.

The proportion of patients who attain an improvement
of inflammation (characterised as improvement of either synovitis (synovialitis or tenosynovitis) or osteitis) in the MRI as measured by the change in the sum of the OMERACT-RAMRIS osteitis
and synovitis score and the tenosynovitis score after 6 months of treatment with abatacept or placebo (i.e. the second MRI visit) compared to baseline.
Secondary Objective: To describe the evolution of clinical and radiological parameters (MRI and HR-pQCT) in patients with ACPA positive arthralgia treated with abatacept s.c. or placebo for 6 months.
Timepoint(s) of evaluation of this end point: After 6 months of treatment with abatacept or placebo
Secondary Outcome(s)
Secondary end point(s): -RAMRIS synovitis, erosion and osteitis scores of the dominant hand after 6, 12, and 18 months
-Tenosynovitis score of the dominant hand after 6, 12, and 18 months
-Proportion of patients with new or persistent arthralgia after 6, 12 and 18 months
-Time to disappearance of arthralgia in the first 6 months
-Proportion of patients with clinical arthritis defined by joint swelling after 6, 12, and 18 months
-Proportion of patients with RA (ACR/EULAR 2010 criteria) after 6 months, 12, and 18 months
-Proportion of patients with radiological progress in HR-pQCT analysis comparing baseline images with end of study images
-TJC 68 and SJC 66 after 3, 6, 9, 12, 15 and 18 months
-DAS28 after 3, 6, 9, 12, 15 and 18 months
-VAS pain, VAS patient global and VAS physician global after 3, 6, 9, 12, 15 and 18 months
-Duration of Joint stiffness 3, 6, 9, 12, 15 and 18 months
-HAQ-DI after 6, 12, and 18 months
-RAID score after 6, 12, and 18 months
-SF-36 score after 6, 12, and 18 months
-Bone mineral density (BMD), bone volume per tissue volume (BV/TV), cortical width and cortical porosity in the micro-CT of the distal radius and metacarpal heads after 18 months
-Gut microbiota composition after 6 and 12 months (unique fraction distance matrices and Bray-Curtis dissimilarities) for patients in the gut microbiota sub-study
Timepoint(s) of evaluation of this end point: 1, 2, 4, 5, 11, 12, 13: After 6, 12, and 18 months
3: In the first 6 months
6, 14: At the end of study (after18 months)
7, 8, 9, 10: After 3, 6, 9, 12, 15 and 18 months
16: After 6 and 12 months
Secondary ID(s)
2014-000555-93-DE
ARIAA
NCT02778906
Source(s) of Monetary Support
Brisol Myers Squibb
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 28/11/2017
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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