A Retrospective, Observational Chart Review of Biologics in Monotherapy Versus the Combination Biologic Plus Methotrexate in Patients With Rheumatoid Arthritis

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 15 sites in United Kingdom.

Completed

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

Trial summary

This cross-sectional, non-interventional, retrospective chart review will compare the efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy in patients with rheumatoid arthritis who have had an inadequate response to prior treatment with disease-modifying anti-rheumatic drugs… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
How many people: 476 participants
Where: 15 sitesUnited Kingdom
Study dates: Apr 2013to Mar 2014
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: Patients with rheumatoid arthritis with an inadequate response to at least 2 DMARD treatments, one of which includes methotrexate, who are being treated with first-line biologic therapy

Who may be able to join

Adult patients, >/= 18 years of age
Diagnosis of rheumatoid arthritis by a rheumatologist
Patients who have responded inadequately to methotrexate or disease-modifying anti-rheumatic drugs (DMARDs) and are being prescribed a biologic in monotherapy or in combination with methotrexate and other classical DMARDs as per NICE guidelines

Who cannot join

Primary diagnosis of a condition other than rheumatoid arthritis
Current treatment with a biologic in combination without methotrexate
Prior treatment with an experimental agent for rheumatoid arthritis

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United Kingdom15 sites

Study site
Cambridge, CB2 0QQ
Study site
Chelmsford, CM1 7ET
Study site
Cosham, PO6 3LY
Study site
Derby, DE22 3NE
Study site
Dudley, DY1 2HQ
Study site
Edinburgh, EH4 2XU
Study site
Harlow, CM20 1QX
Study site
London, E11 1NR
Study site
London, SE13 6LH
Study site
Newcastle upon Tyne, NE7 7DN
Study site
Norwich, NR4 7UY
Study site
Portadown, BT63 5QQ
Study site
Stoke-on-Trent, ST6 7AG
Study site
Truro, TR1 3LJ
Study site
Wigan, WN6 9EW

Other trials in United Kingdom

About this study

Official title: A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Rheumatoid Arthritis: A Comparison of the Effectiveness of Biologic Monotreatment and Biologic and Methotrexate (MTX) Combination Treatment

Conditions: Rheumatoid Arthritis
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

Study groups in NCT01866150
Study group	Role	What they receive
Cohort		Not described

What is being measured

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

Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by [*] the square root [√] of TJC) plus (+) (0.28 * √ of SJC) + (0.70 * the natural logarithm [ln] ESR in millimeters per hour [mm/h]) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score <2.6.
Measured: Month 6

Secondary outcomes (8)

Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment
The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. DAS28 = (0.56 * √ of TJC) + (0.28 * √ of SJC) + (0.70 * ln ESR in mm/h) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score < 2.6.
Measured: Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.
The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6. LDA was defined as a DAS28 score <3.2.
Measured: Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment
The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or C Reactive Protein (CRP) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.
Measured: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Percentage of Participants by Category of DAS28 Score and Timepoint
The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or CRP for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.
Measured: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Duration of Treatment
Drug retention was defined as the total duration of time in months the participant was on treatment (combination therapy or monotherapy). The duration was the time in months between the start date of biologic therapy to the date of most recent visit.
Measured: Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Average Methotrexate Dose of Participants on Biological Combination Treatment
Measured: Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.
The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Measured: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment
The 28 joints to be assessed for swelling were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Measured: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)

Timeline

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

Apr 2013Mar 2014

First posted31 May 2013 (estimated)
Study startApr 2013
Primary completionOct 2013
Study completionMar 2014

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 Hoffmann-La RocheThe 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: 476 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01866150
Sponsor's protocol ID: ML28642
Status last verified: Sep 2015
First submitted: 21 May 2013
Last updated: 5 Oct 2015
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?

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Rheumatoid Arthritis: A Comparison of the Effectiveness of Biologic Monotreatment and Biologic and Methotrexate (MTX) Combination Treatment
ClinicalTrials.gov ID: NCT01866150
Acronym / sponsor ID: ML28642
Conditions: Rheumatoid Arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 476 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Oct 2013 (actual)
Study completion: Mar 2014 (actual)
First posted: 31 May 2013 (estimated)
Results: Posted 5 Oct 2015

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: 1

Arm	Type	Receives
Cohort	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with rheumatoid arthritis with an inadequate response to at least 2 DMARD treatments, one of which includes methotrexate, who are being treated with first-line biologic therapy

Key inclusion criteria (3 listed)

Adult patients, >/= 18 years of age
Diagnosis of rheumatoid arthritis by a rheumatologist
Patients who have responded inadequately to methotrexate or disease-modifying anti-rheumatic drugs (DMARDs) and are being prescribed a biologic in monotherapy or in combination with methotrexate and other classical DMARDs as per NICE guidelines

Key exclusion criteria (3 listed)

Primary diagnosis of a condition other than rheumatoid arthritis
Current treatment with a biologic in combination without methotrexate
Prior treatment with an experimental agent for rheumatoid arthritis

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

Primary outcome

Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)
Time frame: Month 6
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by [*] the square root [√] of TJC) plus (+) (0.28 * √ of SJC) + (0.70 * the natural logarithm [ln] ESR in millimeters per hour [mm/h]) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score <2.6.

8 secondary outcomes

Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment
Time frame: Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.
Time frame: Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment
Time frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Percentage of Participants by Category of DAS28 Score and Timepoint
Time frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Duration of Treatment
Time frame: Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Average Methotrexate Dose of Participants on Biological Combination Treatment
Time frame: Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.
Time frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment
Time frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)

Results and safety

Results posted to the registry on 5 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Population	450	450

Primary outcome: Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)

Time frame: Month 6. Number. Unit: percentage of participants

Measure	Biologic Monotherapy n = 114	Biologic Combination n = 191
Value	30.7	31.9

Biologic Monotherapy vs Biologic Combination: Treatment Difference: 1.2 (95% CI -9.5 to 12.0), p = 0.8222, Pearson's chi-squared

Population analysed: Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR at Month 6.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to the last visit after initiation of first line biologic treatment (maximum 147.1 months for monotherapy and 189.1 months for combination therapy). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biologic Monotherapy	0 of 7 (0%)	0 of 7 (0%)	Not reported
Biologic Combination	0 of 9 (0%)	2 of 9 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Clinical Trials study director

Hoffmann-La Roche

15 sites 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 Hoffmann-La Roche at 15 sites in United Kingdom.

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 3 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 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United Kingdom. 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 5 Oct 2015). 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?

Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6) (time frame: Month 6). 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 NCT01866150.

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 5 Oct 2015.