Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis

NCT01563978 | Completed Phase 2 Results DMC

• 2 other identifiers: D4300C000332011-006070-73
• Study Type: interventional
• Target: 266
• Locations: 7 countries
• Sites: 56

Brief Summary

The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a disease-modifying anti-rheumatic drug (DMARD). The study will last for 57 days.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 24-hour Mean Ambulatory SBP

  ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.

  4 weeks

Secondary Outcomes (9)

• Change From Baseline in 24-hour Mean Ambulatory DBP

  4 weeks

• Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring

  4 weeks

• Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring

  4 weeks

• Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring

  4 weeks

• Mean Change From Baseline in Clinic SBP and DBP

  4 weeks

Study Arms (2)

Dosing Regimen A

EXPERIMENTAL

Oral treatment

Drug: fostamatinib

Dosing Regimen B

PLACEBO COMPARATOR

Oral treatment

Drug: placebo

Interventions

fostamatinib DRUG

fostamatinib 100 mg twice daily

Dosing Regimen A

placebo DRUG

placebo

Dosing Regimen B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18 or over diagnosed with rheumatoid arthritis after the age of 16
• Active rheumatoid arthritis defined as: ≥4 swollen joints and ≥4 tender/painful joints (from 28 joint count) and either erythrocyte sedimentation rate ≥28 mm/h, or C-reactive protein ≥10 mg/L.
• Currently taking one of the following disease-modifying anti-rheumatic drugs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.
• Patients without essential hypertension or with essential hypertension if their blood pressure is controlled (\<140/90 mmHg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation.

You may not qualify if:

• Females who are pregnant or breastfeeding.
• Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
• History of liver problems that have required previous investigations
• Evidence of tuberculosis infection
• Conditions that preclude or render difficult the 24-hour ambulatory blood pressure monitoring technique.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (56)

Research Site

Huntsville, Alabama, United States

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Huntington Beach, California, United States

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Santa Maria, California, United States

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Trumbull, Connecticut, United States

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Boca Raton, Florida, United States

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Brandon, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Venice, Florida, United States

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Decatur, Georgia, United States

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South Bend, Indiana, United States

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Cumberland, Maryland, United States

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Frederick, Maryland, United States

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Hagerstown, Maryland, United States

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Florissant, Missouri, United States

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Richmond Heights, Missouri, United States

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Freehold, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Lake Oswego, Oregon, United States

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Duncansville, Pennsylvania, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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Nassau Bay, Texas, United States

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Tacoma, Washington, United States

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Sevlievo, Bulgaria

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Sofia, Bulgaria

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Brno, Czechia

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Hlučín, Czechia

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Hostivice, Czechia

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Kladno, Czechia

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Ostrava-Trebovice, Czechia

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Prague, Czechia

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Aachen, Germany

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Halle, Germany

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Gdynia, Poland

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Grodzisk Mazowiecki, Poland

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Kalisz, Poland

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Katowice, Poland

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Lodz, Poland

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Poznan, Poland

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Środa Wielkopolska, Poland

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Wroclaw, Poland

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Bloemfontein, South Africa

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Cape Town, South Africa

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Durban, South Africa

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Kempron Park, South Africa

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Donetsk, Ukraine

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Kyiv, Ukraine

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Vinnytsia, Ukraine

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Zaporizhzhya, Ukraine

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dave Goldstraw
• Organization: AstraZeneca Pharmaceuticals

dave.goldstraw@astrazeneca.com

+44-1625-512415

Study Officials

• Chris O'Brien, MD PhD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 27, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 8, 2014
• Results First Posted: April 14, 2014

Record last verified: 2014-04

Locations

PL (8); ZA (4); UA (4); CZ (6); DE (2); BU (2); US (30)