Rheumatoid ArthritisPhase 2NCT01752855

Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

A Phase 2 study testing New formulation adalimumab in people with Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 20 sites in 7 countries.

Completed

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

Official record

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Trial summary

A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation. 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?: New formulation adalimumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 20 sitesin 7 countries
Study dates: Dec 2012to Oct 2013
Phase: Phase 2
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

Who may be able to join

Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):
Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
Hormonal contraceptives for 90 days prior to study drug administration;
A vasectomized partner.
Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.

Who cannot join

Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
Subject plans to use any live vaccine during the study.
Positive pregnancy test at Baseline (Week 0).
Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Trial locations and contacts

20 sites in 7 countries.

Country

City, postcode or hospital

20 sites in 7 countries

United States6 sites

Site Reference ID/Investigator# 92114
Charleston, South Carolina, 29406
Site Reference ID/Investigator# 92115
Clifton, New Jersey, 07012
Site Reference ID/Investigator# 92118
Hemet, California, 92543
Site Reference ID/Investigator# 92113
Mesa, Arizona, 85202
Site Reference ID/Investigator# 92116
Philadelphia, Pennsylvania, 19152
Site Reference ID/Investigator# 92117
Wichita, Kansas, 67203

Other trials in United States

Czechia4 sites

Site Reference ID/Investigator# 91954
Brno, 638 00
Site Reference ID/Investigator# 91955
Prague, 128 50
Site Reference ID/Investigator# 91953
Uherské Hradiště, 686 01
Site Reference ID/Investigator# 91956
Zlín, 760 01

Other trials in Czechia

Romania3 sites

Site Reference ID/Investigator# 92093
Bucharest, 020475
Site Reference ID/Investigator# 92095
Cluj-Napoca, 400006
Site Reference ID/Investigator# 92094
Ploieşti, 100337

Other trials in Romania

Slovakia3 sites

Site Reference ID/Investigator# 92096
Banská Bystrica, 97405
Site Reference ID/Investigator# 92097
Senica, 905 01
Site Reference ID/Investigator# 92098
Žilina, 010 01

Other trials in Slovakia

Belgium2 sites

Site Reference ID/Investigator# 92053
Brussels, 1200
Site Reference ID/Investigator# 92054
Liège, 4000

Other trials in Belgium

Germany1 site

Site Reference ID/Investigator# 92073
Ratingen, 40882

Other trials in Germany

Puerto Rico1 site

Site Reference ID/Investigator# 92074
Vega Baja, 00693

Other trials in Puerto Rico

About this study

Official title: A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab

Read the detailed description

All participants who completed Study NCT01712178 had an opportunity to enroll into the study and to receive the new adalimumab formulation at a dose of 40 mg every other week (eow) for an additional 24 weeks.

Conditions: Rheumatoid Arthritis
Being tested: New formulation adalimumab
Keywords: 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.

New formulation adalimumabBiological
Also called Humira
New formulation adalimumab 40 mg every other week

Study groups in NCT01752855
Study group	Role	What they receive
New formulation of adalimumab 40 mg every other week	Experimental	New formulation adalimumab 40 mg every other week Receives: Biological: New formulation adalimumab

What is being measured

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

Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48
The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48
American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
- ≥ 20% improvement in tender joint count;
- ≥ 20% improvement in swollen joint count; and
- ≥ 20% improvement in at least 3 of the 5 following parameters:
- Physician global assessment of disease activity
- Patient global assessment of disease activity
- Patient assessment of pain
- Disability Index of the Health Assessment
- CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Measured: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48
American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:
- ≥ 50% improvement in tender joint count;
- ≥ 50% improvement in swollen joint count; and
- ≥ 50% improvement in at least 3 of the 5 following parameters:
- Physician global assessment of disease activity
- Patient global assessment of disease activity
- Patient assessment of pain
- Disability Index of the Health Assessment
- CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Measured: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.
Measured: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

Secondary outcomes (1)

Percentage of Participants Positive for Anti-adalimumab Antibody
Percentage of participants with anti-adalimumab antibody
Measured: Week 24 through Week 48

Timeline

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

Dec 2012Oct 2013

First posted19 Dec 2012 (estimated)
Study startDec 2012
Primary completionOct 2013
Study completionOct 2013

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.
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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01752855
Sponsor's protocol ID: M13-692
Other IDs: 2012-003881-42
Status last verified: Oct 2014
First submitted: 17 Dec 2012
Last updated: 29 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab
ClinicalTrials.gov ID: NCT01752855
Acronym / sponsor ID: M13-692
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 19 Dec 2012 (estimated)
Results: Posted 29 Oct 2014

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
New formulation of adalimumab 40 mg every other week	Experimental	Biological: New formulation adalimumabNew formulation adalimumab 40 mg every other week

Who may qualify

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

Key inclusion criteria (8 listed)

Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):
Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.

Key exclusion criteria (5 listed)

Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
Subject plans to use any live vaccine during the study.
Positive pregnancy test at Baseline (Week 0).
Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

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
New formulation adalimumabAlso: HumiraNew formulation adalimumab 40 mg every other week	Biological	New formulation of adalimumab 40 mg every other week

Primary outcome

Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48
Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48
Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment * CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48
Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment * CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))
Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48
Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.

1 secondary outcome

Percentage of Participants Positive for Anti-adalimumab Antibody
Time frame: Week 24 through Week 48

Results and safety

Results posted to the registry on 29 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
New Formulation for 48 Weeks	44	43
Current Formulation for 24 Weeks, New Formulation for 24 Weeks	44	40

Primary outcome: Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48

Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48. Mean (Standard Deviation). Unit: units on a scale

Measure	New Formulation for 48 Weeks n = 44	Current Formulation for 24 Weeks, New Formulation for 24 Weeks n = 44
Week 36	-2.4 (1.17)	-2.2 (1.05)
Week 48	-2.4 (1.29)	-2.2 (1.28)

Population analysed: All available data were included. If a participant did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.

Primary outcome: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48

Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48. Number. Unit: percentage of participants

Measure	New Formulation for 48 Weeks n = 44	Current Formulation for 24 Weeks, New Formulation for 24 Weeks n = 44
Week 36	72.7	76.7
Week 48	74.4	80.0

Population analysed: All participants who received at least one dose of study drug.

Primary outcome: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48

Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48. Number. Unit: percentage of participants

Measure	New Formulation for 48 Weeks n = 44	Current Formulation for 24 Weeks, New Formulation for 24 Weeks n = 44
Week 36	50.0	51.2
Week 48	53.5	57.5

Population analysed: All participants who received at least one dose of study drug.

Primary outcome: Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48

Time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48. Mean (Standard Deviation). Unit: units on a scale

Measure	New Formulation for 48 Weeks n = 44	Current Formulation for 24 Weeks, New Formulation for 24 Weeks n = 43
Week 36	-0.5 (0.60)	-0.5 (0.69)
Week 48	-0.5 (0.57)	-0.5 (0.58)

Population analysed: Data from participants receiving the new formulation of adalimumab in Study NCT01712178 were analyzed for 44 and 43 participants, respectively, at weeks 36 and 48. Data for the participants receiving the current formulation of adalimumab in Study NCT01712178 were analyzed for 43 participants at week 36 and 40 participants at week 48.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of study drug administration until 70 days following the last dose, approximately 58 weeks. Serious adverse events were collected from the time the participant signed the informed consent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
New Formulation for 48 Weeks	2 of 44 (4.5%)	18 of 44 (40.9%)	Not reported
Current Formulation for 24 Weeks, New Formulation for 24 Weeks	1 of 44 (2.3%)	19 of 44 (43.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US Prescribing Information for approved uses.Link provided by the sponsor.

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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.

Andy Payne, PhD study director

AbbVie

20 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing New formulation adalimumab in people with Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 20 sites in 7 countries.

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 8 inclusion and 5 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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Czechia, Romania, Slovakia, Belgium and 2 more countries. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2014). 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?

Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48 (time frame: Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48). The study lists 4 primary outcomes in all. 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 NCT01752855.

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 29 Oct 2014.