GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 124

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1. Patients must give written informed consent before any study-related assessment is performed.
2. Patients must be = 18 years of age.
3. Patients must have a diagnosis of Rheumatoid Arthritis, based on the ACR 1987 criteria.
At least 4 of the following 7 criteria must be fulfilled (and criteria a. through d. must have been present for at least 6 weeks) to confirm the diagnosis of RA:
a. joint morning stiffness of at least one hour
b. swelling of joints in at least three joint areas, diagnosed by a doctor, c. swelling of MCP and wrist joints, diagnosed by a doctor
d. bilateral, symmetric swelling of joints in the same joint areas, diagnosed by a doctor
e. rheumatoid nodule
f. rheumatoid factor seropositivity
g. positive findings in hand radiographs.
4. Patients must have had the diagnosis of RA for at least 6 months at Visit 2.
5. Patients must have active RA at baseline (Visit 2):
• = 6 swollen joints (of 66 joints assessed)
• = 6 tender joints (of 68 joints assessed)
• CRP = 10 mg/L
ORESR = 28 mm/1st hour
Note: If one of the above criteria is not met at Visit 2, the patient is not eligible for randomization at this time point. A re-assessment (i.e., an additional Visit 2) can be done once within 14 days at the discretion of the investigator. A patient can repeat the whole screening phase (be re-screened) only once.
6. Patients must be seropositive for rheumatoid factor (RF) and/or have antibodies to cyclic citrullinated peptide (anti-CCP) at Visit 1.

For additional inclusion criteria, please refer to section 4.1 of the protocol.
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 99
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Patients eligible for inclusion in this study must not fulfill any of the following criteria:
1. RA patients with functional status class IV classified according to the ACR 1991 revised criteria.
2. Patients with levels of serum IgG, IgM and IgA below LLN at Visit 1 and/or Visit 2.
3. Patients with systemic manifestations of RA, with the exception of Sjögren’s syndrome.
4. Patients taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine).
5. Female patients nursing (lactating / breast-feeding), pregnant or planning of pregnancy within 12 months after the last infusion of study drug, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (cut-off as defined by the central laboratory).
6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and intrauterine devices (IUDs)). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
7. Patients who have had any therapy with intra-articular injections (e. g. corticoid) required by a flare up to 4 weeks before randomization.

For additional exclusion criteria, please refer to section 4.2 of the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 11/24/2021

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Recruitment & Eligibility

Study & Design

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