Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX - Full Text View

Purpose

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: CP-690,550 Drug: Disease-modifying antirheumatic drug	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase 3 Randomized, Double-Blind Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Compared To Methotrexate In Methotrexate-Naive Patients With Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Autoimmune Diseases Foot Health Joint Disorders Rheumatoid Arthritis X-Rays

Drug Information available for: Methotrexate Methotrexate sodium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Comparison of baseline and month 6 scores of PA hand and AP foot radiographs obtained, read and scored by a central facility [ Time Frame: comparison of baseline and month 6 ] [ Designated as safety issue: No ]
ACR 70 responder rate [ Time Frame: month 6 and all other timepoints ] [ Designated as safety issue: No ]
Incidence and severity of adverse events and clinical laboratory abnormalities [ Time Frame: all time points ] [ Designated as safety issue: Yes ]
Summary of changes in physical examination compared to baseline by patient [ Time Frame: all time points ] [ Designated as safety issue: Yes ]
Mean change from baseline in vital signs (blood pressure, heart rate, and temperature) measurements; categorical summary of absolute vital signs and vital sign changes compared to baseline by patient [ Time Frame: all time points ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline of scores of PA hand and AP foot radiographs [ Time Frame: month 12, 24 ] [ Designated as safety issue: No ]
Patients who drop out of A3921069 early will have radiographs obtained at last study visit, if previous radiographs were obtained more than 3 months prior to end of study visit. [ Time Frame: all time points ] [ Designated as safety issue: No ]
Period radiographs will be obtained in all patients who discontinue from this study and enroll in open-label, long-term study A3921024. Changes in joint structure seen in A3921024 will be scored using validated method, similar to that used in this study. [ Time Frame: all time points ] [ Designated as safety issue: No ]
ACR 20, 50, and 70 responder rates [ Time Frame: all time points ] [ Designated as safety issue: No ]
DAS 28-3 (CRP) and DAS 28-4 (CRP) [ Time Frame: all time points ] [ Designated as safety issue: No ]
DAS 28-3 (ESR) and DAS 28-4 (ESR) at participating sites (dependent upon availability of a local laboratory that can report ESR results directly to the central laboratory, to ensure blinding of data). [ Time Frame: all time points ] [ Designated as safety issue: No ]
Physical function and patient reported outcomes [ Time Frame: various timepoints ] [ Designated as safety issue: No ]

Enrollment:	968
Study Start Date:	January 2010
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 5 mg BID CP-690,550	Drug: CP-690,550 Oral tablets administered at a dose of 5 mg BID for 24 months
Experimental: 10 mg BID CP-690,550	Drug: CP-690,550 Oral tablets administered at a dose of 10 mg BID for 24 months
Active Comparator: methotrexate	Drug: Disease-modifying antirheumatic drug Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months Other Name: DMARD, MTX

Eligibility

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

Criteria

Inclusion Criteria:

Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL

Exclusion Criteria:

Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
History of any other rheumatic autoimmune disease other than Sjogren's syndrome
No malignancy or history of malignancy
History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039688

Show 163 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01039688 History of Changes
Other Study ID Numbers:	A3921069
Study First Received:	December 23, 2009
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

oral JAK inhibitor
MTX
DMARD
clinical trial

joint diseases
autoimmune diseases
anti-Inflammatory agents
rheumatic diseases

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Methotrexate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal

Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013

Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX (ORAL1069)