Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

Phase 1

Conditions: Rheumatoid Arthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2014-000110-61-DE

Lead Sponsor: Fujifilm Kyowa Kirin Biologics Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 680

Inclusion Criteria

1. Have completed all 24 weeks of study procedures (including dosing) according to protocol FKB32-002, with a minimum of 9 doses of study drug received, and are continuing with stable concomitant MTX and folate.
2. In the investigator’s opinion, the patient showed a clinical response to treatment during Study FKB327 002.
3. Are willing to participate in the study and have provided written informed consent.
4. Females of childbearing potential must have a negative pregnancy test prior to study dosing.
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 580
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Evidence of a serious adverse event (SAE) ongoing from Study FKB327-002 at entry to this study, including a serious infection, malignancy, or any other condition that may put patients at increased risk when receiving treatment with adalimumab.
2. Presence of active and/or untreated latent tuberculosis (TB) as detected by QuantiFERON test at Week 22 combined with chest X-ray at Week 24 in Study FKB327-002. Latent TB, treated with prophylactic antimycobacterial therapy for at least 3 weeks before study dosing is resumed, is acceptable. Patients may have up to a maximum of 4 weeks interruption of dosing between the last dose in Study FKB327-002 and Week 0 dosing in study FKB327-003 for this purpose.
3. Were non compliant with FKB327-002 study procedures, or with any condition or circumstances, which, in the opinion of the Investigator,
makes them unlikely or unable to comply with study procedures and requirements.
4. American College of Rheumatology (ACR) Functional Class IV.