Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

An observational study of Rheumatoid Arthritis, run by Pfizer at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study involves review and analysis of disease activity in patients with rheumatoid arthritis who where treated with either conventional DMARDs (Disease Modifying Antirheumatic Drugs) or Biologics and have two existing, consecutive radiographs (x-ray images) of hand and feet taken as part of routine treatment… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: DMARDs or Biologics
How many people: 156 participants
Where: 1 siteDenmark
Study dates: Aug 2009to Jun 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 200

Who may be able to join

Secure diagnosis of rheumatoid arthritis
Older than 18 years
Two consecutive plain radiographs of the hands and feet with a time interval of 12 to 36 months are available. The radiographs are recorded 2003 or later and are in accordance with a defined X-ray protocol.

Who cannot join

Patients who receive Anakinra, Rituximab or Abatacept

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Study site
Schmittingheide 20-32, Munster, 48155

Other trials in Denmark

About this study

Official title: A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.

Conditions: Rheumatoid Arthritis
Being tested: DMARDs or Biologics
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DMARDs or BiologicsDrug

Study groups in NCT00929357
Study group	Role	What they receive
1		DMARDs Receives: Drug: DMARDs or Biologics
2		Biologics Receives: Drug: DMARDs or Biologics

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression
Radiographic progression assessed using Ratingen score with range of 0 = normal joint; 1 = one or more erosions, <20% of the joint surface are destroyed; 2 = 21% to 40% of the joint surface are destroyed; 3 = 41% to 60% of joint surface are destroyed; 4 = 61% to 80% of the joint surface are destroyed; 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. Annualized change in Ratingen score calculated as (total change in Ratingen score / time period between radiograph 1 and 2 [months])*12 months.
Measured: Baseline (Day 0) up to 48 months

Secondary outcomes (7)

Number of Participants Without Radiographic Progression
An increase of 4 or more points in the Ratingen score was necessary to detect a difference in radiographic progression. Ratingen score range 0 = normal joint to 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. A decrease of 4 (smallest detectable difference) or more points in total Ratingen score was considered a decrease in erosive damage.
Measured: Baseline (Day 0) up to 48 months
Number of Participants Without Erosions
Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.
Measured: Baseline (Day 0) up to 48 months
Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Measured: Baseline (Day 0) up to 48 months
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).
Measured: Baseline (Day 0) up to 48 months
Change From Baseline in C-reactive Protein (CRP)
C-reactive protein measured as milligrams per liter (mg/l)
Measured: Baseline (Day 0) up to 48 months
Number of Participants With Change From Baseline in Rheumatoid Factor (RF)
Rheumatoid Factor measured as a titer and categorized as negative (<1:16 ratio) or positive. A ratio >1:16 indicates a higher level of RF.
Measured: Baseline (Day 0) up to 48 months
Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)
Cyclic citrullinated peptide-autoantibody-test measured as Enzyme-linked immunosorbent assay (ELISA units or EU) and categorized as negative (<20 EU) or positive (≥20 up to >60 EU).
Measured: Baseline (Day 0) up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Jun 2010

First posted29 Jun 2009 (estimated)
Study startAug 2009
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00929357
Sponsor's protocol ID: 0881X1-4617
Status last verified: Aug 2011
First submitted: 25 Jun 2009
Last updated: 10 Aug 2011
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.
ClinicalTrials.gov ID: NCT00929357
Acronym / sponsor ID: 0881X1-4617
Conditions: Rheumatoid Arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 29 Jun 2009 (estimated)
Results: Posted 28 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
1	–	Drug: DMARDs or BiologicsDMARDs
2	–	Drug: DMARDs or BiologicsBiologics

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 200

Key inclusion criteria (3 listed)

Secure diagnosis of rheumatoid arthritis
Older than 18 years
Two consecutive plain radiographs of the hands and feet with a time interval of 12 to 36 months are available. The radiographs are recorded 2003 or later and are in accordance with a defined X-ray protocol.

Key exclusion criteria (1 listed)

Patients who receive Anakinra, Rituximab or Abatacept

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DMARDs or Biologics	Drug	1, 2

Primary outcome

Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression
Time frame: Baseline (Day 0) up to 48 months
Radiographic progression assessed using Ratingen score with range of 0 = normal joint; 1 = one or more erosions, <20% of the joint surface are destroyed; 2 = 21% to 40% of the joint surface are destroyed; 3 = 41% to 60% of joint surface are destroyed; 4 = 61% to 80% of the joint surface are destroyed; 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. Annualized change in Ratingen score calculated as (total change in Ratingen score / time period between radiograph 1 and 2 [months])*12 months.

7 secondary outcomes

Number of Participants Without Radiographic Progression
Time frame: Baseline (Day 0) up to 48 months
Number of Participants Without Erosions
Time frame: Baseline (Day 0) up to 48 months
Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)
Time frame: Baseline (Day 0) up to 48 months
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline (Day 0) up to 48 months
Change From Baseline in C-reactive Protein (CRP)
Time frame: Baseline (Day 0) up to 48 months
Number of Participants With Change From Baseline in Rheumatoid Factor (RF)
Time frame: Baseline (Day 0) up to 48 months
Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)
Time frame: Baseline (Day 0) up to 48 months

Results and safety

Results posted to the registry on 28 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DMARDS	92	92
Biologics	64	64

Primary outcome: Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression

Time frame: Baseline (Day 0) up to 48 months. Mean (Standard Deviation). Unit: scores on a scale

Measure	DMARDS n = 92	Biologics n = 64
Baseline Ratingen score - first radiograph	6.9 (10.7)	24.3 (30.7)
Change at second radiograph	0.0 (3.0)	0.3 (6.3)
Annualized change in Ratingen score	-0.1 (1.4)	0.0 (3.3)

Population analysed: Evaluable population: all participants who had provided two evaluable, consecutive radiographs of the hands and forefeet, taken at intervals of 12 to 48 months. Since the time period between the first and second radiograph could range between 12 to 48 months, changes in Ratingen score were to be normalized to 1 year.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 48 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DMARDS	0 of 92 (0%)	0 of 92 (0%)	Not reported
Biologics	0 of 65 (0%)	0 of 65 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Wyeth is now a wholly owned subsidiary of Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Pfizer at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression (time frame: Baseline (Day 0) up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00929357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2011.