Rheumatoid ArthritisNCT01078155

Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis

An observational study of Rheumatoid Arthritis and Osteoporosis, run by AbbVie (prior sponsor, Abbott).

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis, Osteoporosis
How many people: 131 participants
Where: No sites listed yet
Study dates: Mar 2009to May 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 active rheumatoid arthritis

Who may be able to join

Patients with active early and long-standing RA according to American College of Rheumatology (ACR) 1987 revised criteria.
Patients with high disease activity DAS28 ≥ 5.1 according to the Czech Rheumatological Society criteria.
Patients must fulfill national guidelines for use of anti-TNF: inadequate clinical response to at least one disease-modifying antirheumatic drug (DMARD; methotrexate, sulphasalazine, leflunomide, hydroxychloroquine, or combinations) and oral glucocorticoids (equivalent to ≥ 5 mg prednisolone per day), (for Romania except glucocorticoids); chest X-ray, purified protein derivative (PPD)-skin test, Quantiferon/tuberculosis (TB) Gold test (if available) negative for TB.

Who cannot join

Patients who have had a history of TNF blocking or rituximab therapy.
Patients who are being treated or will be treated with drug at risk of interaction with adalimumab (Humira).
Pregnant females and/or females without adequate method of contraception.
Patients who didn't receive prior DMARD therapy.
Patients participating in another study or clinical trial.
Patients with severe osteoporosis (T-score [number that indicates whether or not bone loss has occurred] of ≤ -2.5 and/or prior vertebral fracture/s).

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Patients with a history of total hip replacement of both extremities.
Patients who currently receive and/or received bone metabolism modulating agents including Selective Estrogen Receptor Modulators (SERMs), bisphosphonates, parathyroid hormone or anti-receptor activator of nuclear factor-kappaB ligand (RANKL) therapy.
Subjects who are not eligible for TNF-blocking therapy according to the Czech National Registry (ATTRA).

About this study

This post marketing observational study will be conducted in a prospective, single country, multicenter format to assess the prevention of generalized bone loss in patients with active rheumatoid arthritis (RA) treated with adalimumab (Humira®) in pragmatic prescribing situations. The investigational sites will be centers with experience in the treatment of RA patients and anti-tumor necrosis factor-alpha (TNF-a) therapy. The investigators will be rheumatologists authorized by the Czech Rheumatologic Society for prescribing biological treatment.

Conditions: Rheumatoid Arthritis, Osteoporosis
Keywords: Bone mineral density, Bone turnover markers, Rheumatoid arthritis, Osteoporosis
Medical subject headings: Arthritis, Rheumatoid, Osteoporosis

What participants receive

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

Study groups in NCT01078155
Study group	Role	What they receive
Participants with Active Rheumatoid Arthritis (RA)		Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.

What is being measured

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

Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24
BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines.
Measured: Baseline (Day 0), Month 12, Month 24
Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
T-score and Z-score of spine and hip (L1-L4 and proximal femur) by DEXA. T-score is the number of standard deviations that bone density is above or below the average. A score of ≥ -1 = normal bone density; < -1 and > -2.5 = a sign of osteopenia (bone density below normal); ≤ -2.5 = a sign of osteoporosis. Z-score is the number of standard deviations above or below what's normally expected for someone of matching age, sex, weight, and ethnic or racial origin. A Z-score ≤ -2 may suggest abnormal bone loss due to conditions other than aging.
Measured: Baseline (Day 0), Month 12, Month 24
Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24
Measured: Baseline (Day 0), Month 3, Month 12, Month 24
Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24
Measured: Baseline (Day 0), Month 3, Month 12, Month 24
Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24
Measured: Baseline (Day 0), Month 3, Month 12, Month 24
Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24
Participant-reported the existence and duration of morning stiffness, defined as "morning stiffness in and around the joints, lasting at least 1 hour before maximal improvement."
Measured: Baseline (Day 0), Month 3, Month 12, Month 24
Tender Joint Count at Baseline, Month 3, Month 12, and Month 24
The investigator counted the number of tender joints at each study visit (28 joints are routinely examined).
Measured: Baseline (Day 0), Month 3, Month 12, Month 24

Secondary outcomes (6)

Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24
The investigator counted the number of swollen joints at each study visit (28 joints are routinely examined).
Measured: Baseline (Day 0), Month 3, Month 12, Month 24
Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24
Scores on the DAS28 range from 0 to 10. DAS 28 ≥ 5.1= high RA disease activity; DAS 28 ≥ 3.2 = middle RA disease activity; DAS 28 ≤ 3.2 = lower disease activity; DAS 28 ≤ 2.6 = remission of disease.
Measured: Baseline (Day 0), Month 3, Month 12, Month 24
Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Physician's Global Assessment of Disease Activity VAS was reported on a 100 mm scale, where 0 = very good to 100 = very bad.
Measured: Baseline (Day 0), Month 3, Month 12, Month 24
Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Subject's Global Assessment of Disease Activity VAS was reported on a 100 mm scale, reporting the subject's evaluation of his/her difficulties as 0 = without any difficulty to 100 = significant difficulties.
Measured: Baseline (Day 0), Month 3, Month 12, Month 24
Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24
Subject's Assessment of Pain VAS was reported on a 100 mm scale, where 0 = no pain through 100 = severe pain.
Measured: Baseline (Day 0), Month 3, Month 12, Month 24
Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24
ESR was recorded as per local clinical practice. Normal findings are up to 20 mm/hr for females and up to 15 mm/hr for males.
Measured: Baseline (Day 0), Month 3, Month 12, Month 24

Timeline

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

Mar 2009May 2014

First posted2 Mar 2010 (estimated)
Study startMar 2009
Primary completionMay 2014
Study completionMay 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.
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
Time perspective: Prospective
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01078155
Sponsor's protocol ID: P10-733
Status last verified: May 2015
First submitted: 26 Feb 2010
Last updated: 26 Jun 2015
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?

Official record

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01078155
Acronym / sponsor ID: P10-733
Conditions: Rheumatoid Arthritis, Osteoporosis
Keywords: Bone mineral density, Bone turnover markers, Rheumatoid arthritis, Osteoporosis
Study type: Observational
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 2 Mar 2010 (estimated)
Results: Posted 29 May 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

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Participants with Active Rheumatoid Arthritis (RA)	–	–Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with active rheumatoid arthritis

Key inclusion criteria (3 listed)

Patients with active early and long-standing RA according to American College of Rheumatology (ACR) 1987 revised criteria.
Patients with high disease activity DAS28 ≥ 5.1 according to the Czech Rheumatological Society criteria.
Patients must fulfill national guidelines for use of anti-TNF: inadequate clinical response to at least one disease-modifying antirheumatic drug (DMARD; methotrexate, sulphasalazine, leflunomide, hydroxychloroquine, or combinations) and oral glucocorticoids (equivalent to ≥ 5 mg prednisolone per day), (for Romania except glucocorticoids); chest X-ray, purified protein derivative (PPD)-skin test, Quantiferon/tuberculosis (TB) Gold test (if available) negative for TB.

Key exclusion criteria (9 listed)

Patients who have had a history of TNF blocking or rituximab therapy.
Patients who are being treated or will be treated with drug at risk of interaction with adalimumab (Humira).
Pregnant females and/or females without adequate method of contraception.
Patients who didn't receive prior DMARD therapy.
Patients participating in another study or clinical trial.

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

Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24
Time frame: Baseline (Day 0), Month 12, Month 24
BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines.
Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
Time frame: Baseline (Day 0), Month 12, Month 24
T-score and Z-score of spine and hip (L1-L4 and proximal femur) by DEXA. T-score is the number of standard deviations that bone density is above or below the average. A score of ≥ -1 = normal bone density; < -1 and > -2.5 = a sign of osteopenia (bone density below normal); ≤ -2.5 = a sign of osteoporosis. Z-score is the number of standard deviations above or below what's normally expected for someone of matching age, sex, weight, and ethnic or racial origin. A Z-score ≤ -2 may suggest abnormal bone loss due to conditions other than aging.
Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Participant-reported the existence and duration of morning stiffness, defined as "morning stiffness in and around the joints, lasting at least 1 hour before maximal improvement."
Tender Joint Count at Baseline, Month 3, Month 12, and Month 24
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
The investigator counted the number of tender joints at each study visit (28 joints are routinely examined).

6 secondary outcomes

Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24
Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24
Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

Results and safety

Results posted to the registry on 29 May 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
Participants With Active Rheumatoid Arthritis (RA)	131	87

Primary outcome: Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24

Time frame: Baseline (Day 0), Month 12, Month 24. Mean (Standard Deviation). Unit: g/cm^2

Measure	Participants With Active Rheumatoid Arthritis (RA) n = 87
L1-L4 BMD: Baseline; n=86	1.06 (0.15)
L1-L4 BMD: Month 12; n=71	1.07 (0.17)
L1-L4 BMD: Month 24; n=59	1.06 (0.17)
Proximal Femur BMD: Baseline; n=86	0.88 (0.14)
Proximal Femur BMD: Month 12; n=72	0.91 (0.13)
Proximal Femur BMD: Month 24; n=58	0.90 (0.13)

Population analysed: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.

Primary outcome: Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24

Time frame: Baseline (Day 0), Month 12, Month 24. Mean (Standard Deviation). Unit: standard deviations

Measure	Participants With Active Rheumatoid Arthritis (RA) n = 87
L1-L4 T-score: Baseline; n=85	-0.57 (1.14)
L1-L4 T-score: Month 12; n=71	-0.42 (1.15)
L1-L4 T-score: Month 24; n=58	-0.40 (1.15)
L1-L4 Z-score: Baseline; n=82	-0.02 (1.14)
L1-L4 Z-score: Month 12; n=67	0.15 (1.08)
L1-L4 Z-score: Month 24; n=54	0.21 (1.09)
Proximal Femur T-score: Baseline; n=85	-0.70 (1.11)
Proximal Femur T-score: Month 12; n=72	-0.60 (0.97)

Population analysed: Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.

Primary outcome: Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24

Time frame: Baseline (Day 0), Month 3, Month 12, Month 24. Mean (Standard Deviation). Unit: µg/L

Measure	Participants With Active Rheumatoid Arthritis (RA) n = 87
Baseline - Month 3; n=6	-2.97 (4.68)
Baseline - Month 12; n=9	-2.21 (11.99)
Baseline - Month 24; n=5	1.39 (8.77)

Population analysed: Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.

Primary outcome: Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24

Time frame: Baseline (Day 0), Month 3, Month 12, Month 24. Mean (Standard Deviation). Unit: ng/mL

Measure	Participants With Active Rheumatoid Arthritis (RA) n = 87
Baseline - Month 3; n=8	8.70 (17.78)
Baseline - Month 12; n=11	-1.87 (17.22)
Baseline - Month 24; n=7	15.29 (21.18)

Population analysed: Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 268 weeks and 5 days (adverse event and serious adverse event analyses did not include those cases where the onset followed the last dose of study drug for > 70 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Active Rheumatoid Arthritis (RA)	1 of 131 (0.8%)	11 of 131 (8.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink 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.

Maroš Lipták, MD study director

Abbvie, Czech Republic & Slovakia

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Osteoporosis, run by AbbVie (prior sponsor, Abbott).

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 9 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 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

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 29 May 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?

Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 (time frame: Baseline (Day 0), Month 12, Month 24). The study lists 7 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 NCT01078155.

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 26 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.