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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: 5 August 2013
Main ID:  EUCTR2008-000744-13-IT
Date of registration: 09/01/2009
Prospective Registration: Yes
Primary sponsor: RIGEL PHARMACEUTICALS INC
Public title: 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 - ND
Scientific title: 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 - ND
Date of first enrolment: 28/01/2009
Target sample size: 800
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000744-13
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: in aperto If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase: 
Countries of recruitment
Bulgaria France Germany Italy
Contacts
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Key inclusion & exclusion criteria
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) no
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Reumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Intervention(s)

Product Name: R935788
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fosfamatinib Disodium
CAS Number: 914295-16-2
Current Sponsor code: R935788 sodium hexahydrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: R935788
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fosfamatinib Disodium
CAS Number: 914295-16-2
Current Sponsor code: R935788 sodium hexahydrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)
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).
Primary end point(s): This is an open-label study, with no endpoint.
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.
Secondary Outcome(s)
Secondary ID(s)
2008-000744-13-DE
C-935788-012
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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