A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00713544

Purpose

This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpose of this study is also to find out which dose of AZD5672 is the most effective at treating RA and to find out how well the body tolerates AZD5672 when taken for up to 12 weeks.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: AZD5672 Drug: Etanercept Drug: Placebo	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (With Open-Label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

ACR20 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ACR50, ACR70, Hybrid ACR response, Individual ACR components, DAS 28 [ Time Frame: Baseline, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
ESR [ Time Frame: Baseline, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
Safety outcomes [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	360
Study Start Date:	July 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Etanercept 50 mg, subcutaneous injection, weekly
2: Experimental 20mg	Drug: AZD5672 20 mg oral, once daily
3: Experimental 50mg	Drug: AZD5672 50 mg oral, once daily
4: Experimental 100mg	Drug: AZD5672 100 mg oral, once daily
5: Experimental 150mg	Drug: AZD5672 150 mg oral, once daily
6: Placebo Comparator	Drug: Placebo placebo, oral, once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated ESR or CRP.
At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of positive rheumatoid factor (blood test), baseline radiographic erosion, presence of serum anti-cyclic citrullinated peptide antibodies (bloo
Be receiving either: Oral (tablets) or subcutaneous (injection) methotrexate for at least 6 months prior to randomisation.

Exclusion Criteria:

Any other inflammatory disease in addition to RA that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, etc).
Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713544

Contacts

Contact: AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Show 68 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Mark Layton	AstraZeneca
Principal Investigator:	Paul P Tak, MD, PhD	University of Amsterdam

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Mark Layton MD, Medical Science Director )
Study ID Numbers:	D1710C00009
Study First Received:	July 9, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00713544
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Bulgaria: Bulgarian Drug Agency; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Netherlands: Medicines Evaluation Board (MEB); Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovakia: State Institute for Drug Control; Ukraine: Ministry of Health

Keywords provided by AstraZeneca:

Rheumatoid Arthritis
RA
AZD5672

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases

Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases
TNFR-Fc fusion protein

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009