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

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2008-000744-13-DE
• Date of registration: 07/10/2008
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• 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
• 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
• 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: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Belgium, Bulgaria, France, Germany, Italy

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
a) An ICF Addendum must be signed by any patient with a history of thrombo-embolic event(s) (e.g., deep vein thrombosis, pulmonary embolism, etc.) or abnormal activated protein C (APC) resistance test result (< LLN for the central reference laboratory) to acknowledge the increased risk of experiencing similar events because of the prior history of thrombo-embolic event(s) or abnormal APC resistance. It is unknown whether or not exposure to R788 will further increase such risk.
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 pregnancy test at the time of entry and at each laboratory determination. See Appendix IX for the list of acceptable contraceptive methods for use during this study.

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 or Tuberculosis;
f)interstitial pneumonitis or active pulmonary infection;
g)known laboratory abnormalities: ALT > 1.2x ULN, Alk Phos > 2x ULN, creatinine > 1.5x ULN, an ANC < 1,500/mm3 or 1.5 x 109/L, Hgb < 9 g/dL or 5 mmol/L, platelet count < 125,000/mm3 or 125 x 109/L 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

Rheumatoid 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: Fostamatinib Disodium
CAS Number: 914295-16-2
Current Sponsor code: R935788 sodium hexahydrate
Other descriptive name: R788 Sodium, R788 Na, R788
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: R935788
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib Disodium
CAS Number: 914295-16-2
Current Sponsor code: R935788 sodium hexahydrate
Other descriptive name: R788 Sodium, R788 Na, R788
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): This is an open-label study with no end point.

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.

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 ID(s)

C-935788-012