Trial Outcomes & Findings for Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-3) (NCT NCT00665626)

NCT ID: NCT00665626

Last Updated: 2017-05-01

Results Overview

The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 3 months

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 219 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2017-05-01

Participant Flow

The first participant received the first dose of study drug on 28 May 2008; the last participant completed the study on 09 June 2009. Participants were recruited from centers in the United States, Europe and Latin America.

Male/female participants who had active rheumatoid arthritis (RA) for a minimum of 12 months and who had failed prior biologic therapy were randomly assigned to receive R788 100 mg twice daily or placebo. It was planned to randomize approximately 195 participants.

Participant milestones

Measure	Placebo Placebo to R788, oral tablets, twice daily, double-blind	R788 100 mg Bid R788 100 mg, oral tablets, twice daily, double-blind
Overall Study STARTED	73	146
Overall Study COMPLETED	63	124
Overall Study NOT COMPLETED	10	22

Reasons for withdrawal

Measure	Placebo Placebo to R788, oral tablets, twice daily, double-blind	R788 100 mg Bid R788 100 mg, oral tablets, twice daily, double-blind
Overall Study Lack of Efficacy	8	5
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	0	1
Overall Study Protocol Violation	0	2
Overall Study Adverse Event	1	9
Overall Study Due to exclusion criteria	0	1
Overall Study Did not fulfil inclusion criteria	0	1
Overall Study Unably to comply with dosing regimen	0	1
Overall Study Death	1	0

Baseline Characteristics

Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-3)

Baseline characteristics by cohort

Measure	Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind	Total n=219 Participants Total of all reporting groups
Age, Continuous	56.0 Years STANDARD_DEVIATION 12.29 • n=5 Participants	56.0 Years STANDARD_DEVIATION 11.45 • n=7 Participants	56.0 Years STANDARD_DEVIATION 11.71 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	117 Participants n=7 Participants	176 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	29 Participants n=7 Participants	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Intent-to-treat population

The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 3 months

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
American College of Rheumatology 20 (ACR20) Response at 3 Months	27 Participants	56 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Intent-to-treat population

The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
American College of Rheumatology 50 (ACR50) Response at 3 Months	9 Participants	32 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Intent-to-treat population

The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
American College of Rheumatology 70 (ACR70) Response at 3 Months	4 Participants	13 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Intent-to-treat population

The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment

Outcome measures

Measure	Arm 1 - Placebo n=63 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=124 Participants R788 100 mg, oral tablets, twice daily, double-blind
American College of Rheumatology Index of Improvement (ACRn) at 3 Months	19.85 Score Standard Deviation 25.604	25.95 Score Standard Deviation 28.624

SECONDARY outcome

Timeframe: 3 months

Population: Intent-to-Treat Population with CRP as Primary Phase Reactant

Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

Outcome measures

Measure	Arm 1 - Placebo n=41 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=88 Participants R788 100 mg, oral tablets, twice daily, double-blind
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months	1 Participants	11 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Intent-to-Treat Population with CRP as Primary Phase Reactant

Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.

Outcome measures

Measure	Arm 1 - Placebo n=41 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=88 Participants R788 100 mg, oral tablets, twice daily, double-blind
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months	4 Participants	21 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Intent-to-Treat Population with ESR as Primary Phase Reactant

Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms

Outcome measures

Measure	Arm 1 - Placebo n=21 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=36 Participants R788 100 mg, oral tablets, twice daily, double-blind
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Intent-to-Treat Population with ESR as Primary Phase Reactant

Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.

Outcome measures

Measure	Arm 1 - Placebo n=21 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=36 Participants R788 100 mg, oral tablets, twice daily, double-blind
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 1 week

Population: Intent-to-treat population

The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 1 week.

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
American College of Rheumatology 20 (ACR20) Response at Week 1	12 Participants	41 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Intent-to-treat population

The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 2 weeks

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
American College of Rheumatology 20 (ACR20) Response at Week 2	14 Participants	44 Participants

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.

Change from baseline in RAMRIS erosion score (a measure of bone erosion in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The erosion score runs from 0 to 250 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.

Outcome measures

Measure	Arm 1 - Placebo n=60 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=115 Participants R788 100 mg, oral tablets, twice daily, double-blind
Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Erosion Score at 3 Months	0.94 Score Standard Deviation 1.740	0.78 Score Standard Deviation 2.174

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.

Change from baseline in RAMRIS osteitis score (a measure of bone inflammation in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The osteitis score runs from 0 to 75 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.

Outcome measures

Measure	Arm 1 - Placebo n=60 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=115 Participants R788 100 mg, oral tablets, twice daily, double-blind
Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Osteitis Score at 3 Months	1.17 Score Standard Deviation 4.848	-0.19 Score Standard Deviation 5.340

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Intent-to-treat population with available data and received study drug. The discrepancy in the lower number of subjects than those in the ITT population is because 43 subjects either never had a complete set of MRIs (pre and post-study) or had uninterpretable results.

Change from baseline in RAMRIS synovitis score (a measure of inflammation in the joints of the hands and wrists), calculated as the score at 3 months minus the score at baseline. The synovitis score runs from 0 to 24 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.

Outcome measures

Measure	Arm 1 - Placebo n=60 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=115 Participants R788 100 mg, oral tablets, twice daily, double-blind
Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Synovitis Score at 3 Months	0.35 Score Standard Deviation 1.791	-0.52 Score Standard Deviation 2.499

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)	8 Participants	14 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)	7 Participants	7 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with ALT (a test of liver function) values greater than 3 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)	0 Participants	6 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with ALT (a test of liver function) values greater than 10 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)	4 Participants	11 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with AST (a test of liver function) values greater than 1.5 to 2 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with AST (a test of liver function) values greater than 3 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Aspartate Aminotransferase (AST) >5-10x Upper Limit of Normal (ULN)	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with AST (a test of liver function) values greater than 10 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Aspartate Aminotransferase (AST) >10x Upper Limit of Normal (ULN)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Alkaline Phosphatase >1.5x Upper Limit of Normal (ULN) and >1.5x Baseline	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Bilirubin >1.5x Upper Limit of Normal (ULN)	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Bilirubin >2x Upper Limit of Normal (ULN)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Any time between baseline and 3 months

Population: Intent-to-treat population

The number of participants with ANC values less than 1500/mm3

Outcome measures

Measure	Arm 1 - Placebo n=73 Participants Placebo to R788, oral tablets, twice daily, double-blind	Arm 2 - R788 100 mg Bid n=146 Participants R788 100 mg, oral tablets, twice daily, double-blind
Absolute Neutrophil Count (ANC) <1500/mm3	0 Participants	9 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

R788 100 mg Bid

Serious events: 13 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=73 participants at risk Placebo to R788, oral tablets, twice daily, double-blind	R788 100 mg Bid n=146 participants at risk R788 100 mg, oral tablets, twice daily, double-blind
Cardiac disorders Coronary Artery Stenosis	0.00% 0/73	0.68% 1/146
Gastrointestinal disorders Vomiting	0.00% 0/73	0.68% 1/146
General disorders Chest Pain	0.00% 0/73	1.4% 2/146
General disorders Asthenia	0.00% 0/73	0.68% 1/146
General disorders Pyrexia	0.00% 0/73	0.68% 1/146
Hepatobiliary disorders Hepatotoxicity	0.00% 0/73	0.68% 1/146
Infections and infestations Pneumonia	0.00% 0/73	1.4% 2/146
Infections and infestations Osteomyelitis	0.00% 0/73	0.68% 1/146
Infections and infestations Septic Shock	1.4% 1/73	0.00% 0/146
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/73	0.68% 1/146
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/73	0.68% 1/146
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/73	0.68% 1/146
Nervous system disorders Sciatica	0.00% 0/73	0.68% 1/146
Nervous system disorders Transient Ischaemic Attack	0.00% 0/73	0.68% 1/146
Renal and urinary disorders Renal Failure Acute	0.00% 0/73	0.68% 1/146

Other adverse events

Measure	Placebo n=73 participants at risk Placebo to R788, oral tablets, twice daily, double-blind	R788 100 mg Bid n=146 participants at risk R788 100 mg, oral tablets, twice daily, double-blind
Blood and lymphatic system disorders Neutropenia	0.00% 0/73	5.5% 8/146
Gastrointestinal disorders Diarrhoea	6.8% 5/73	11.6% 17/146
Gastrointestinal disorders Nausea	2.7% 2/73	8.9% 13/146
Gastrointestinal disorders Abdominal Pain Upper	1.4% 1/73	6.2% 9/146
Infections and infestations Upper Respiratory Tract Infection	5.5% 4/73	8.2% 12/146
Investigations Transaminases Increased	0.00% 0/73	5.5% 8/146
Musculoskeletal and connective tissue disorders Muscle Spasms	6.8% 5/73	0.68% 1/146
Nervous system disorders Headache	2.7% 2/73	9.6% 14/146
Vascular disorders Hypertension	4.1% 3/73	13.0% 19/146

Additional Information

Anne-Marie Duliege, MD

Rigel

Phone: 650-624-1100

Email: clinicaltrials@rigel.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60