An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Conditions: Rheumatoid Arthritis
MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

Registration Number: EUCTR2008-000744-13-FR

Lead Sponsor: Rigel Pharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 800

Inclusion Criteria

1) Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study
2) Patients who are being treated in Study C-788-006X
3) Patients who completed Studies C-788-010 or C-788-011 and did not withdraw due to adverse events
4) Patients who withdrew from Study C-788-010 at Month 4 or Month 5 because of a pre-defined lack of efficacy
5)Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative urine pregnancy test at the time of entry and at each laboratory determination.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator’s opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:
a)unresolved Grade 2 or greater toxicity in a RA protocol studying R788.
b)uncontrolled or poorly controlled hypertension;
c)recent (within past 2 months) serious surgery or infectious disease;
d)recent history (since enrollment in prior R788 study) of, or treatment for, a malignancy other than non-melanomatous skin cancer, or any history of lymphoma;
e)known to be positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis;
f)interstitial pneumonitis or active pulmonary infection;
g)known laboratory abnormalities: ALT > 2x ULN, Alk Phos > 2x ULN, or ANC < 1,500/mm3 are excluded.
2)The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine = 3 oz or 89 mL; 80 proof distilled spirits = 1.5 oz or 44 mL.
3)The patient is unable to report for clinical and laboratory monitoring as per protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to investigate the long term safety of R788 in patients with Rheumatoid Arthritis (RA) who completed the treatment phase of Study C 935788 006X (C 788 006X), C 935788 010 (C 788 010), or C 935788-011 (C 788 011).;Secondary Objective: The secondary objective of this study is to investigate the long term efficacy of R788 in patients with RA who completed the treatment phase of Study C 788 006X, C 788 010, or C 788 011.;Primary end point(s): This is an open-label study with no end point.

Secondary Outcome Measures