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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03652961
Date of registration: 23/08/2018
Prospective Registration: Yes
Primary sponsor: NYU Langone Health
Public title: Rheumatoid Arthritis Memory B Cells and Abatacept (RAMBA) RAMBA
Scientific title: Rheumatoid Arthritis Memory B Cells and Abatacept (RAMBA)
Date of first enrolment: June 2, 2019
Target sample size: 25
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03652961
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Ashley Switzer
Address: 
Telephone: 603-650-4717
Email: Ashley.e.ladd@hitchcock.org
Affiliation: 
Name:     Rebecca E Cohen
Address: 
Telephone: 646-501-0578
Email: Rebecca.Cohen@nyulangone.org
Affiliation: 
Name:     William Rigby, MD
Address: 
Telephone:
Email:
Affiliation:  Dartmouth-Hitchcock Medical Center
Name:     Gregg Silverman, MD
Address: 
Telephone:
Email:
Affiliation:  NYU Langone Health
Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed Written Informed Consent

1. Subject is willing to participate in the study and has signed the informed consent.

- Target Population

1. Men or women (not nursing or pregnant) over 18 years old who have active
Rheumatoid Arthritis, defined as symptoms of Rheumatoid Arthritis prior to
screening and have satisfied the American College of Rheumatology/ European
League Against Rheumatism 2010 criteria for the classification of Rheumatoid
Arthritis prior to signing t the informed consent.

2. Subjects must have a Disease Activity Score 28-joint count C reactive protein
(CRP) or Clinical Disease Activity Index (CDAI) assessment at screening and have
at least 3 tender and at least 3 swollen joints (excluding distal interphalangeal
joints) at screening and at Day 1. Patients must have at least moderate disease
activity {CDAI>16); Disease Activity Score and C-reactive protein test (DAS28CRP
(>4.0 )].

3. Subjects must be naive to biologic Disease-modifying antirheumatic drugs (DMARDs)

4. Subjects must be naive to targeted synthetic DMARDs such as tofacitinib,
baricitinib, and investigational therapies for RA.

5. Subjects receiving oral corticosteroids must be on a stable dose and at the
equivalent of 10 mg prednisone daily for at least 4 weeks. Subjects may not
receive an intravenous (IV), intramuscular (IM) or intra-arterial (IA)
administration of a corticosteroid within 4 weeks prior to screening visit or
initiation of therapy

6. Patients with prior (including discontinued) therapy with Methotrexate and/or
Hydroxychloroquine are permitted as long as they meet other inclusionary
criteria.

7. Subjects must have a DAS28CRP and Clinical Disease Activity Index (CDAI) at
screening and have at least 3 tender and at least 3 swollen joints (excluding
distal interphalangeal joints) at screening and at Day 1.

- Age and Reproductive Status

1. Men and women, age's 18 years (or age of majority)

2. Women of childbearing potential (WOCBP) must have a negative serum or urine

3. pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within

4. 24 hours prior to the start of study drug.

5. Women must not be breastfeeding and must agree not to breastfeed during the study
and for 100 days thereafter

6. WOCBP must agree to follow instructions for method(s) of contraception for the
duration of treatment with study drug plus 5 half-lives of study drug (70 days)
plus 30 days (duration of ovulatory cycle) for a total of 100 days post-treatment
completion.

7. Males who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception for the duration of treatment with study drug, plus 5
half- lives of the study drug (70 days) plus 90 days (duration of sperm turnover)
for a total of 160 days post-treatment completion.

8. Azoospermic males and WOCBP who are continuously not heterosexually active are
exempt from contraceptive requirements. However they must still undergo pregnancy
testing as described in this section. Investigators shall counsel WOCBP and male
subjects who are sexually active with WOCBP on the importance of pregnancy
prevention and the implications of an unexpected pregnancy.

9. Investigators shall advise WOCBP and male subjects who are sexually active with
WOCBP on the use of highly effective methods of contraception. Highly effective
methods of contraception have a failure rate of < 1% when used consistently and
correctly.

10. At a minimum, subjects must agree to use one highly effective method of
contraception as listed below.

- Highly effective methods of contraception

1. Highly effective methods of contraception have a failure rate of < 1% when used
consistently and correctly. WOCBP and female partners of male subjects, who are
WOCBP, are expected to use one of the highly effective methods of contraception
listed below. Male subjects must inform their female partners who are WOCBP of
the contraceptive requirements of the protocol and are expected to adhere to
using contraception with their partner.

1. Progestogen only hormonal contraception associated with inhibition of
ovulation.

2. Hormonal methods of contraception including oral contraceptive pills
containing estrogen + progesterone, vaginal ring, injectables, implants and
intrauterine devices (IUDs) such as Mirena

3. Nonhormonal IUDs, such as ParaGard

4. Bilateral Tubal occlusion

5. Vasectomized partner with documented azoospermia 90 days after procedure

2. Vasectomized partner is a highly effective birth control method provided that
partner is the sole sexual partner of the WOCBP trial participant and that the
vasectomized partner has received medical assessment of the surgical success.

3. Intrauterine hormone-releasing system (IUS)

4. Complete abstinence- Complete abstinence is defined as the complete avoidance of
heterosexual intercourse

1. complete abstinence is an acceptable form of contraception for all study
drugs and must be used throughout the duration of the study treatment (plus
5 half-lives of the investigational drug plus 30 days).

2. It is not necessary to use any other method of contraception when complete
abstinence is elected.

3. Subjects who choose complete abstinence must continue to have pregnancy
tests

4. Acceptable alternate methods of highly effective contraception must be
discussed in the event that the subject chooses to forego complete
abstinence.

5. The reliability of sexual abstinence needs to be evaluated in relation to
the duration of the clinical trial and the preferred and usual lifestyle of
the subject.

- Unacceptable methods of contraception

1. Periodic abstinence (calendar, symptothermal, post-ovulation methods)

2. Withdrawal (coitus interruptus)

3. Spermicide only

4. Lactation amenorrhea method (LAM)

Exclusi



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Primary Outcome(s)
Clinical response of abatacept and conventional synthetic disease-modifying anti-rheumatic drugs to induce low disease activity- [Time Frame: 24 weeks]
Clinical response of abatacept and conventional synthetic disease-modifying anti-rheumatic drugs to induce low disease activity- PBMC collection [Time Frame: 24 weeks]
Secondary Outcome(s)
Quantification of relationships between co-primary endpoints over time and then confirm this relationship by dechallenge of Abatacept after induction of low disease activity at 24 weeks - Clinical Disease Activity Index (CDAI). [Time Frame: 24 weeks]
Quantification of relationships between co-primary endpoints over time and then confirm this relationship by dechallenge of Abatacept after induction of low disease activity at 24 weeks - Disease Activity Score using C-reactive protein test. [Time Frame: 24 weeks]
Quantification of relationships between co-primary endpoints over time and then confirm this relationship by dechallenge of Abatacept after induction of low disease activity at 24 weeks - RAPID-3 questionnaire [Time Frame: 24 weeks]
Quantification of relationships between co-primary endpoints over time and then confirm this relationship by dechallenge of Abatacept after induction of low disease activity at 24 weeks - tender and swollen joint count [Time Frame: 24 Weeks]
Secondary ID(s)
s18-01164
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Dartmouth-Hitchcock Medical Center
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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