NCT00746512

Brief Summary

The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Sep 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 8, 2011

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

September 3, 2008

Results QC Date

December 17, 2010

Last Update Submit

May 7, 2015

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Synovial Blood Flow

    Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.

    Baseline and Day 14

Secondary Outcomes (1)

  • Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])

    Baseline and Day 14

Study Arms (4)

Prednisone 15 mg

EXPERIMENTAL

Prednisone 15 mg tablets once daily for 15 days

Drug: Prednisone 15 mg

Placebo 15 mg

PLACEBO COMPARATOR

Prednisone 15 mg placebo tablets once daily for 15 days

Drug: Placebo Tablets

Prednisone 7.5 mg

EXPERIMENTAL

Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.

Drug: Prednisone 7.5 mg

Placebo 7.5 mg

PLACEBO COMPARATOR

Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.

Drug: Placebo Over-Encapsulated Tablets

Interventions

Prednisone 15 mgDRUG

Prednisone 15 mg tablets once daily for 15 days.

Also known as: Prednisone
Prednisone 15 mg
Placebo TabletsDRUG

Prednisone placebo tablets once daily for 15 days.

Placebo 15 mg
Prednisone 7.5 mgDRUG

Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days

Also known as: Prednisone
Prednisone 7.5 mg
Placebo Over-Encapsulated TabletsDRUG

Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days

Placebo 7.5 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is willing to limit alcohol intake to 3 or less beverages per day
  • Patient agrees to use only acetaminophen/paracetamol for breakthrough pain

You may not qualify if:

  • Patient has other inflammatory arthritis (e.g. lupus). Patient has had major surgery or donated or lost 1 unit of blood in the last 4 weeks
  • Patient has a history of drug or alcohol abuse in the last 2 years
  • Patient has had a vaccine (with a live or attenuated virus) in the last two weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Seymour MW, Kelly S, Beals CR, Malice MP, Bolognese JA, Dardzinski BJ, Cheng AS, Cummings CE, Smugar SS, McClinton C, Fox A, Dooley WM, Pitzalis C, Taylor PC. Ultrasound of metacarpophalangeal joints is a sensitive and reliable endpoint for drug therapies in rheumatoid arthritis: results of a randomized, two-center placebo-controlled study. Arthritis Res Ther. 2012 Sep 12;14(5):R198. doi: 10.1186/ar4034.

    PMID: 22972032RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Prednisone

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2008

First Posted

September 4, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 29, 2015

Results First Posted

April 8, 2011

Record last verified: 2015-05